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MEDICINES AND RELATED SUBSTANCES ACT 101 OF 1965

The Act was amended by Act 90 of 1997 and Act 59 of 2002 and (apart from Sections 18 A and 26) it came into operation on 2 May 2003.  Sections 18 A (Bonusing) will come into operation on 2 May 2004 and Section 26 (Inspectors-authorisation) will come into operation on 1 July 2005. 

Sections and subsections extracted from the Act,  circulated with the Council's June 2003 Newsletter 33 and is published for the information of the Veterinary and Para-Veterinary Professions. 

Visit the following websites for full details: www.gov.za/acts/02index , www.doh.gov.za/docs/regulations/medcontrol and www.mccza.com .

Your attention is in particular drawn to the extracts from the Act and Regulations as follows:

Bonusing (Section 18 A) (2 May 2004)

No person shall supply any medicine according to a bonus system, rebate system or any incentive scheme.  Kindly in this regard refer to Council's policy on Perverse Incentives as published under policies on this website.  policies on this website.

Control of Medicines and Scheduled substances (Section 22 A)

Council negotiated on behalf of the Veterinary profession that: Veterinarians are not required to obtain an additional license to prescribe, compound or dispense Schedule 2, Schedule 3, Schedule 4, Schedule 5 or Schedule 6 substances and any medicine or scheduled substance may be possessed by a veterinarian, registered under the Veterinary and Para-Veterinary Professions Act, 1982, for the purposes of administering it in accordance with his or her scope of practice.

RELEVANT REGULATIONS

11(1) A prescription book or other permanent record in respect of Schedule 2,3,4,5, and 6 medicines or substances shall be kept on all premises where prescribed medicines are dispensed or sold and shall contain the following details:

a. the name of the medicine or scheduled substance;

b. the date on which the prescription was dispensed;

c. the dosage form and quantity of the medicine or scheduled substance;

d. the name and address of the patient, or, in the case of a prescription issued by a veterinarian, the name and address of the person to whom the medicine or scheduled substance was sold;

e. where applicable the name of the medical practitioner, dentist, veterinarian or any other authorised person who issued the prescription; and

f. prescription reference number.

(2) In the case of Schedule 1 medicine sold without a prescription in terms of  section 22 A (4) of the Act, the following shall be recorded:

a. the name of the person to whom it was sold;

b. its name and quantity; and

c. the name of the pharmacist or intern pharmacist or pharmacist assistant who sold it.

(3) A prescription record shall be retained at the business address of the seller for a period of at least five years after the date of the last entry made therein.

(4) The manufacturer or wholesaler shall keep a record of Schedule 2,3,4 and 5 medicines and substances in the form of invoices that will reflect:

a. the date and transaction of every sale;

b. the name of the medicine;

c. the name and address of every purchaser;

d. the quantities sold;

e. the batch number; and

f. the price at which the medicine was sold.

(5) A record referred to in subregulation (4) shall be kept for a period of five years from the date of sale.

Destruction of Medicines

27. (1) A medicine or scheduled substance may be destroyed as follows:

a. A medicine containing Schedule 5,6,7 or 8 substance may only be destroyed in the presence of an inspector, an officer of the South African Police Service or any other person authorised by the Director-General.  Such inspector, person or officer, as the case may be, shall issue a certificate confirming the destruction of the medicine and in the case of an officer, the case number must be entered in the register;

b. Notwithstanding paragraph (a), the Council may authorise the destruction of Schedules 5 or 6 substance by a manufacturer of such substances in the absence of an inspector;

c. In the case of Schedule 1,2,3 and 4 substance or medicine, a pharmacist or an authorised person in charge of a place where medicines or substances are kept may destroy such medicines or substances.  Such pharmacist or authorised person shall certify such destruction.

(2) No medicines may be disposed of into municipal sewerage systems.

(3) The destruction or disposal of medicines or scheduled substances must be conducted in such a manner as determined by the Council to ensure that they are retrievable.   

Register of specified Schedule 5, Schedules 5 or 6 Medicines or Substances

30 (1) A person importing, exporting, manufacturing or selling specified Schedule 5, Schedule 5 or 6 medicines or substances shall keep a register of such medicines or substances.

(2) The register referred to in subregulation (1) must indicate the quantity of every such medicine or substance remaining in stock on the last day of March, June, September and December of each year and must also contain the following information:

a. The date on which the medicine or substance was received or supplied;

b. The name, business address of the person from whom the medicine or substance was received or sent and in the case of imported medicine or substance, the import permit number;

c. The name and address of the person who purchased the medicine or substance;

d. The quantity, in words and figures, of such medicine or substance indicated per dosage unit, mass or volume;

e. In the case of the supply of the medicine or substance on prescription, the name and address of the authorised prescriber unless such prescription was issued at a hospital in which case the name of the authorised prescriber shall be recorded;

f. The quantity of the medicine or substance manufactured or used during the manufacturing process; and

g. Any other information as the Council may determine.

(3) The register referred to in subregulation (1) must be kept for a period of five years after the date of the last entry made therein.

(4) In a case where the register is kept by computer, a computer print out must be made monthly, dated, signed and filed.

(5) Records must be stored in an orderly manner so that they can be accessed easily.

33. The repacking of the medicines into patient ready packs-

a. may only be carried out by-

i. a pharmacist or under the supervision of a pharmacist; or

ii. any other person authorised in terms of section 29 (4) of the Pharmacy Act, 1974

b. must have a batch numbering system which contains all the information relating to the ingredients and the procedures used in preparing the patient ready pack;

c. must be carried out under the required temperature and humidity conditions;

d. must be carried out in an area of the premises specially  used for pre-packing only; and

e. must be carried out in accordance with good manufacturing and distribution practices.

Kindly note that regulation 33 does not pertain to dispensing, but must be read with Section 34 of the Veterinary and Para-Veterinary Professions Act as follows:

A person who is registered...to practise a veterinary profession, may personally compound or dispense any medicine which is prescribed by himself or by any other person with whom he is in partnership or with whom he is associated as a principal or an assistant or a locum tenens, for use in the treatment of an animal which is under his professional care:  Provided that he shall not be entitled to keep an open shop or pharmacy.


Package Inserts for Veterinary Medicines

40(1) The immediate container of a veterinary medicine that is sold must have the following information with regard to the medicine which is in at least one official language and in minimum legibility:

a. the propriety name;

b. scheduling status;

c. dosage form;

d. composition, using generic approved names;

e. pharmacological classification;

f. pharmacological action;

g. pharmokinetic properties and pharmacodynamic properties;

h. contra-indications;

i. warnings or withdrawal period in the case of food producing animals;

j. side-effects and special precautions;

k. known signs of overdose and particulars of its treatment;

l. quantity and strength of active ingredients per dosage unit;

m. storage instructions;

n. registration number;

o. name and business address of holder of certificate of registration; and

p. any other information as the Council may from time to time determine.

(2) The Council may from time to time deviate from subregulation (1).

Labelling of Veterinary Medicines- Regulation 48(4) determines that you should label medicines sold and or prescribed by you as follows:

i. The name of the medicine or the name of each active ingredient or constituent medicine, unless the relevant prescription issued by the veterinarian concerned has been clearly marked with the words 'non nomen propium';

ii. the name of the person to whom such medicine has been sold and a description, as accurate as possible, of the animals for which the treatment is intended;

iii. the directions for the use of such medicine;

iv. the name and address of the veterinarian or pharmacist who has sold such medicine;

v. the reference number allocated to the sale of the medicine as referred to in regulation 11(1) (f); and where applicable, the warning, referred to in reg.48 (1) par.s (medicine intended to be used in food producing animals) regarding the withdrawal period of such medicine;

vi. date of dispensing.

EXTRACTS FROM MEDICINES AND RELATED SUBSTANCES CONTROL ACT 101 OF 1965

as amended by:

Medicines and Related Substances Control Amendment Act 90 of 1997

Medicines and Related Substances Amendment Act 59 of 2002

A NUMBER OF SECTIONS AND SUBSECTIONS OF NOTE ARE HIGHLIGHTED IN BOLD AND UNDERLINED

ACT

To provide for the registration of medicines and related substances intended for human and for animal use; to provide for the establishment of a Medicines Control Council; to provide that such council shall be a juristic person; to make other provision for the constitution of the council; to provide that a member of the council or committee shall declare his or her commercial interest related to the pharmaceutical or health care industry; to provide that the appointment of members of the executive committee is subject to the approval of the Minister; to provide for the control of medicines and scheduled substances and medical devices; to make further provision for the prohibition on the sale of medicines which are subject to registration and are not registered; to provide for procedures that will expedite the registration of essential medicines, and for the re-evaluation of all medicines after five years; to provide for measures for the supply of more affordable medicines in certain circumstances; to provide that labels be approved by the council; to prohibit sampling and bonusing of medicines; to provide for the licensing of certain persons to compound, dispense or manufacture medicines and medical devices and also to act as wholesalers or distributors; to provide for the generic substitution of medicines; to provide for the establishment of a pricing committee; to regulate the purchase and sale of medicines by manufacturers, distributors, wholesalers, pharmacists and persons licensed to dispense medicines; to make new provisions for appeals against decisions of Director-General or the council; to provide that the council may acquire and appropriate funds; to regulate the Minister’s power to make regulations; to provide for the rationalization of certain laws relating to medicines and related substances that have remained in force in various territories on the national territory of the Republic of South Africa, 1996; and to provide for matters connected therewith.

1. Definitions

(1) In this Act, unless the context otherwise indicates-

'advertisement', in relation to any medicine or Scheduled substance, means any written, pictorial, visual or other descriptive matter or verbal statement or reference-

(a) appearing in any newspaper, magazine, pamphlet or other publication; or

(b) distributed to members of the public; or

(c) brought to the notice of members of the public in any manner whatsoever,

which is intended to promote the sale of that medicine or Scheduled substance; and 'advertise' has a corresponding meaning;

'approved name', in relation to a medicine, means the international non proprietary name (INN) of such medicine or, where no such name exists, such other name as the council may determine, not being a brand name or trade name registered in terms of the Trade Marks Act, 1993 (Act 194 of 1993);

'certificate of registration' means a certificate of registration issued under section 15 (4), 15A (4) or 15 (B) (4);

'council' means the Medicines Control Council established by section 2;

'dentist' means a person registered as such under the Health Professions Act, 1974;

'Director-General' means the Director-General: Health;

'export' includes deliver or supply within the Republic for dispatch to any destination outside the Republic;

'hospital' means any institution established as a hospital or a nursing home or registered as such in terms of any law;

'immediate container', in relation to a medicine or Scheduled substance, means a container which is in direct contact with the medicine or substance;

'interchangeable multi-source medicine' means medicines that contain the same active substances which are identical in strength or concentration, dosage form and route of administration and meet the same or comparable standards, which comply with the requirements for therapeutic equivalence as prescribed;

'inspector' means a person authorized as such under section 26;

'label', when used as a verb, means brand, mark or otherwise designate or describe, and when used as a noun, means any brand or mark or any written, pictorial or other descriptive matter appearing on or attached to or packed with and referring to any article or the package containing any article;

'magistrate' means a magistrate as defined in section 1 of the Magistrates Act. 1993 ( Act No.90 of 1993), and includes an additional magistrate and an assistant magistrate;

'medical device' means any instrument, appliance, material, machine, apparatus, implant or diagnostic reagent-

(a) used or purporting to be suitable for use or manufactured or sold for use in-

1. the diagnosis, treatment, mitigation, modification, monitoring or prevention of disease, abnormal physical or mental states or the symptoms thereof; or
2. restoring, correcting or modifying any somatic or psychic or organic function; or
3. the diagnosis or prevention of pregnancy,

and which does not achieve its purpose through chemical, pharmacological, immunological or metabolic means in or on the human body but which may be assisted in its function by such means; or

(b) declared by the Minister by notice in the Gazette to be a medical device,

and includes any part or an accessory of a medical device;

'medical practitioner' means a person registered as such under the Health Professions, 1974and includes an intern registered under that Act;

'medicine' means any substance or mixture of substances used or purporting to be suitable for use or manufactured or sold for use in-

(a) the diagnosis, treatment, mitigation, modification or prevention of disease, abnormal physical or mental state or the symptoms thereof in man; or

(b) restoring, correcting or modifying any somatic or psychic or organic function in man,

and includes any veterinary medicine;

'Minister' means the Minister of Health;

'nurse' means a person registered as such under the Nursing Act, 1978 (Act 50 of 1978);

'package' means anything in or by which any medicine or Scheduled substance is enclosed, covered, contained or packed;

'pathologist' means a pathologist to whom authority has been granted under section 27;

'pharmacist' means a person registered as such under the Pharmacy Act, 1974;

'pharmacist intern' means a person registered as such under the Pharmacy Act, 1974;

'pharmacist's assistant' means a person registered as such under the Pharmacy Act, 1974;

'pharmacologist', except for the purposes of section 24 (1) (c), means a pharmacologist to whom authority has been granted under section 27;

'practitioner' means a person registered as such under the Allied Health Professions Act, 1982 (Act 63 of 1982);

'prescribed' means prescribed by or under this Act;

'public' includes a section of the public concerned with manufacturing, dispensing, selling or administering, or the issue of prescriptions for, medicines or a Scheduled substance;

'register', when used as a noun, means the register referred to in section 13, and when used as a verb, means to enter in such register;

'registered' means entered in the register;

'registrar' means the Registrar of Medicines appointed under section 12;

'regulation' means a regulation made and in force under this Act;

'Scheduled substance' means any medicine or other substance prescribed by the Minister under section 22A;

'sell' means sell by wholesale or retail and includes import, offer, advertise, keep, expose, transmit, consign, convey or deliver for sale or authorize, direct or allow a sale or prepare or possess for purposes of sale, and barter or exchange or supply or dispose of to any person whether for a consideration or otherwise; and 'sale' and 'sold' have corresponding meanings;

'this Act' includes any regulation;

'veterinarian' means a person registered as such under the Veterinary and Para-Veterinary Professions Act, 1982 (Act 19 of 1982);

'veterinary medicine' means any substance or mixture of substances, other than a stock remedy or farm feed to be registered in terms of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947), used or purporting to be suitable for use or manufactured or sold for use in connection with vertebrates, for the treatment, diagnosis, prevention or cure of any disease, infection or other unhealthy condition, or for the maintenance or improvement of health, growth, production or working capacity, or for curing, correcting or modifying any somatic or organic function, or for correcting or modifying behaviour.

(2) Subject to section 15C, a medicine shall, notwithstanding the fact that its components are identical to those of any other medicine as to physical characteristics, quantity and quality, for the purpose of this Act not be regarded as being the same medicine as that other medicine if registration thereof is not applied for by the holder of the certificate of registration issued in respect of that other medicine.

(3) In determining whether or not the registration or availability of a medicine is in the public interest, regard shall be had only to the safety, quality and therapeutic efficacy thereof in relation to its effect on the health of man or any animal, as the case may be.

(4) International tendering for medicines shall be allowed in the prescribed manner and on the prescribed conditions.

14. Prohibition on the sale of medicines which are subject to registration and are not registered

(1) Save as provided in this section or sections 21 and 22A, no person shall sell any medicine which is subject to registration by virtue of a resolution published in terms of subsection (2) unless it is registered.

(2) (a) The council may from time to time by resolution approved by the Minister, determine that a medicine or class or category of medicines or part of any class or category of medicines mentioned in the resolution shall be subject to registration in terms of this Act.

(b) Any such resolution may also relate only to medicines which were available for sale in the Republic immediately prior to the date on which it comes into operation in terms of paragraph (c) or only to medicines which were not then so available.

(c) Any such resolution shall be published in the Gazette by the registrar and shall come into operation on the date on which it is so published.

(3) In the case of a medicine which was available for sale in the Republic immediately prior to the date of publication in the Gazette of the resolution by virtue of which it is subject to registration in terms of this Act, the provisions of subsection (1) shall come into operation-

(a) if no application for the registration of such medicine is made within the period of six months immediately succeeding that date, on the expiration of that period; or

(b) if application for the registration of such medicine is made within the said period, on the date one month after the date on which a notice in respect of such medicine is published in the Gazette in terms of section 15 (10) or section 17 (a).

(4) The provisions of subsection (1) shall not apply in respect of the sale of any medicine-

(a) compounded in the course of carrying on his or her professional activities by a pharmacist, veterinarian or person who is the holder of a license contemplated in section 22C (1) (a), for a particular patient in a quantity not greater than the quantity required for treatment as determined by the medical practitioner, pharmacist, practitioner or veterinarian; or

(b) compounded by a pharmacist in a quantity not greater than that prescribed by regulation for sale in the retail trade, subject to the conditions likewise prescribed or in a quantity for a particular person or animal as prescribed by a medical practitioner or a dentist or a veterinarian or a practitioner or a nurse or other person registered under the Health Professions Act, 1974, and referred to in section 22A, as the case may be,

if such medicine does not contain any component the sale of which is prohibited by this Act or any component in respect of which an application for registration has been rejected, and is not or has not been advertised: Provided that the active components of such medicine appear in another medicine which has been registered under this Act.

15C - Measures to ensure supply of more affordable medicines

The Minister may prescribe conditions for the supply of more affordable medicines in certain circumstances so as to protect the health of the public, and in particular may-

(a) notwithstanding anything to the contrary contained in the Patents Act, 1978 (Act 57 of 1978), determine that the rights with regard to any medicine under a patent granted in the Republic shall not extend to acts in respect of such medicine which has been put onto the market by the owner of the medicine, or with his or her consent;

(b) prescribe the conditions on which any medicine which is identical in composition, meets the same quality standard and is intended to have the same proprietary name as that of another medicine already registered in the Republic, but which is imported by a person other than the person who is the holder of the registration certificate of the medicine already registered and which originates from any site of manufacture of the original manufacturer as approved by the council in the prescribed manner, may be imported;

(c) prescribe the registration procedure for, as well as the use of, the medicine referred to in paragraph (b).

18. Labels and advertisements

(1) No person shall sell any medicine or Scheduled substance unless the immediate container or the package in which that medicine or Scheduled substance is sold bears a label stating the prescribed particulars.

(2) No person shall advertise any medicine or Scheduled substance for sale unless such advertisement complies with the prescribed requirements.

(3) The label referred to in subsection (1) shall be approved by the council.

(4) The council may authorise a deviation from the prescribed format and contents of any label.

(5) The Minister may prescribe additional requirements for the labelling of medicines.

18A. Bonusing

No person shall supply any medicine according to a bonus system, rebate system or any other incentive scheme.

18B. Sampling of medicines

(1) No person shall sample any medicine.

(2) For the purposes of this section 'sample' means the free supply of medicines by a manufacturer or wholesaler or its agent to a pharmacist, medical practitioner, dentist, veterinarian, practitioner, nurse or other person registered under the Health Professions Act, 1974, but does not include the free supply of medicines for the purposes of clinical trials, donations of medicines to the State, tendering to the State and quality control by inspectors.

(3) The use of medicines or Scheduled substances for exhibition purposes shall be as prescribed.

18C. Marketing of medicines

The Minister shall, after consultation with the pharmaceutical industry and other stakeholders, make regulations relating to the marketing of medicines, and such regulations shall also provide for an enforceable Code of Practice.

19. Prohibition on sale of medicines which do not comply with prescribed requirements and furnishing of information regarding medicines to the council

(1) No person shall sell any medicine unless it complies with the prescribed requirements.

(2) The council may by notice in writing require any person who manufactures or sells or administers or prescribes any medicine or on whose direction any medicine is administered to furnish it, within a period stipulated in such notice, with any information which such person has in his possession or which such person is in a position to obtain regarding such medicine.

(3) The council may, if so requested by any person to whom a notice under subsection (2) is addressed, extend the period stipulated in such notice.

20. Publication or distribution of false advertisements concerning medicines

(1) No person shall-

(a) publish or distribute or in any other manner whatsoever bring to the notice of the public or cause or permit to be published or distributed or to be so brought to the notice of the public any false or misleading advertisement concerning any medicine; or

(b) in any advertisement make any claim to the effect that the therapeutic efficacy and effect of any medicine is other than that stated by the council in terms of sub-paragraph (ii) of paragraph (a) of section twenty-two or state or suggest that any medicine should be used for a purpose or under circumstances or in a manner other than that stated by the council in terms of sub-paragraph (iii) or paragraph (a) of that section.

(2) It shall be a sufficient defence in any prosecution for an offence under paragraph (a) of sub-section (1) if it is proved to the satisfaction of the court that the accused, not being a person selling the medicine to which the false or misleading advertisement which is the subject of the prosecution relates, did not know, and could not reasonably be expected to have known, that the advertisement was in any respect false or misleading, unless it is proved that the accused failed on demand by the registrar or an inspector or a member of the South African Police to furnish the name and address of the person at whose instance the advertisement was published, distributed or so brought to the notice of the public.

21. Council may authorize sale of unregistered medicine for certain purposes

(1) The council may in writing authorize any person to sell during a specified period to any specified person or institution a specified quantity of any particular medicine which is not registered.

(2) Any medicine sold in pursuance of any authority granted under sub-section (1) may be used for such purposes and in such manner and during such period as the council may in writing determine.

(3) The council may at any time by notice in writing withdraw any authority granted in terms of sub-section (1) if effect is not given to any determination made in terms of sub-section (2).

22. Director-General to cause certain information to be furnished

(1) The Director-General shall after consultation with the council, cause, in such manner as the Director-General considers most suitable-

(a) as soon as practicable after any medicine, other than a veterinary medicine, has been registered, medical practitioners, dentists, pharmacists and the person who applied for the registration of such medicine to be informed-

(i) of the name and number under which such medicine is registered and the conditions, if any, subject to which such medicine is registered;

(ii) of the therapeutic efficacy and effect of such medicine;

(iii) of the purpose for which, the circumstances under which and the manner in which such medicine should be used; and

(iv) regarding any other matter concerning such medicine which, in the opinion of the council, may be of value to them;

(b) as soon as practicable after the registration of any medicine, other than a veterinary medicine, has been cancelled in terms of section 16, medical practitioners, dentists, pharmacists and the holder of the certificate of registration issued in respect of such medicine to be informed of the cancellation of such registration.

(2) The provisions of subsection (1) shall apply mutatis mutandis in respect of any veterinary medicine, and for the purposes of such application the reference in that subsection to medical practitioners and dentists shall be deemed to be a reference to veterinarians.

22A Control of medicines and Scheduled substances

(1) Subject to this section, no person shall sell, have in his or her possession or manufacture any medicine or Scheduled substance, except in accordance with the prescribed conditions.

(2) The Minister may, on the recommendation of the council, prescribe the Scheduled substances referred to in this section.

(3) Any Schedule 0 substance may be sold in an open shop.

(4) Any Schedule 1 substance shall not be sold-

(a) by any person other than-

(i) a pharmacist, or a pharmacist intern or pharmacist's assistant acting under the personal supervision of a pharmacist;

(ii) a manufacturer of or wholesale dealer in pharmaceutical products for sale to any person who may lawfully possess such substance;

(iii) a medical practitioner or dentist, who may-

(aa) prescribe such substance;

(bb) compound and dispense such substance only if he or she is the holder of a licence as contemplated in section 22C (1) (a);

(iv) a veterinarian who may prescribe, compound or dispense such substance;

(v) a practitioner, nurse or a person registered under the Health Professions Act, 1974, other than a medical practitioner or dentist, who may-

(aa) prescribe only the Scheduled substances identified in the Schedule for that purpose;

(bb) compound and dispense the Scheduled substances referred to in item (aa) only if he or she is the holder of a licence contemplated in section 22C (1) (a);

(b) to any person apparently under the age of 14 years except upon a prescription issued by an authorised prescriber and dispensed by a pharmacist, pharmacist intern or pharmacist's assistant or by a veterinarian or a person who is the holder of a licence as contemplated in section 22C (1) (a), or on a written order disclosing the purpose for which such substance is to be used and bears a signature known to the seller as the signature of a person known to such seller and who is apparently over the age of 14 years;

(c) unless the seller, other than a manufacturer or wholesale dealer in pharmaceutical products, enters in a prescription book required to be kept in the prescribed manner, the prescribed particulars of such sale.

5) Any Schedule 2, Schedule 3, Schedule 4, Schedule 5 or Schedule 6 substance shall not be sold by any person other than-

(a) a pharmacist, pharmacist intern or a pharmacist's assistant acting under the personal supervision of a pharmacist, who may sell only Schedule 2 substances without a prescription;

(b) a pharmacist or a pharmacist intern or pharmacist's assistant acting under the personal supervision of a pharmacist, upon a written prescription issued by an authorised prescriber or on the verbal instructions of an authorised prescriber who is known to such pharmacist;

(c) a manufacturer of or wholesale dealer in pharmaceutical products for sale to any person who may lawfully possess such substance;

(d) a medical practitioner or dentist, who may-

(i) prescribe such substance;

(ii) compound or dispense such substance only if he or she is the holder of a licence as contemplated in section 22C (1) (a);

(e) a veterinarian who may prescribe, compound or dispense such substance;

(f) a practitioner, a nurse or a person registered under the Health Professions Act, 1974, other than a medical practitioner or dentist, who may-

(i) prescribe only the Scheduled substances identified in the Schedule for that purpose;

(ii) compound and dispense the Scheduled substances referred to in subparagraph (i) only if he or she is the holder of a licence contemplated in section 22C (1) (a):

(6) Any sale under subsection (5) shall only take place on condition that-

(a) all the prescribed particulars of every sale shall be recorded in the prescribed manner in a prescription book or other permanent record required to be kept in the prescribed manner;

(b) the authorised prescriber who has given verbal instructions to a pharmacist to dispense a prescription shall within seven days after giving such instructions furnish such pharmacist with a prescription confirming such instructions;

(c) in the case of verbal instructions the treatment period shall not exceed seven days;

(d) if a prescription is not presented for dispensing within 30 days of issue it shall not be dispensed;

(e) in the case of a Schedule 2 substance, such substance may not be supplied to any person apparently under the age of 14 years except upon a prescription issued by an authorised prescriber and dispensed by a pharmacist, pharmacist intern or pharmacist's assistant or by a veterinarian or a person who is the holder of a licence as contemplated in section 22C (1) (a), or on a written order disclosing the purpose for which such substance is to be used and bears a signature known to the seller as the signature of a person known to such seller and who is apparently over the age of 14 years;

(f) in the case of a Schedule 2, Schedule 3 or Schedule 4 substance, such sale may be repeated if the person who issued the prescription has indicated thereon the number of times it may be dispensed, but not for longer than six months;

(g) in the case of a Schedule 5 substance, such sale shall not be repeated for longer than six months, and then only if the authorised prescriber has indicated on the prescription the number of times and the intervals at which it may be dispensed;

(h) where a Schedule 5 substance is used for-

(i) its anxiolytic, antidepressant or tranquillising properties it shall not be prescribed for longer than six months unless the authorised prescriber has consulted a registered psychiatrist, or, in the case of a psychiatrist, another psychiatrist before issuing a new prescription;

(ii) its analgesic properties it shall not be prescribed for longer than six months unless the authorised prescriber has consulted another medical practitioner, before issuing a new prescription;

(i) in the case of a Schedule 6 substance, it shall not be repeated without a new prescription being issued;

(j) in an emergency in which the health or life of a patient is at stake, a pharmacist engaged in wholesale practice may, on receipt of a telephonic or telefaxed or other electronic request, supply a Schedule 6 substance to a pharmacist, medical practitioner, dentist, veterinarian, practitioner, nurse or other person registered under the Health Professions Act, 1974, without a written order: Provided that-

(i) it shall be the responsibility of such pharmacist, medical practitioner, dentist, veterinarian, practitioner, nurse or other person to ensure that such pharmacist receives a written order within seven days.

(ii) the Schedule 6 substance shall be supplied in the smallest unit sales pack available;

(iii) a permanent record is made and kept of such supply.

(k) in an emergency a pharmacist may sell any Schedule 5 or Schedule 6 substance in a quantity not greater than that required for continuous use for a period of 48 hours, on the verbal instructions of a medical practitioner, dentist, veterinarian, practitioner, nurse or other person registered under the Health Professions Act, 1974, who is known to such pharmacist, but the prescriber who has given such verbal instructions shall within 72 hours after giving such instructions furnish to such pharmacist a written prescription confirming the instructions;

(l) in an emergency a pharmacist may sell a Schedule 2, Schedule 3 or Schedule 4 substance on a non-recurring basis for a period not exceeding 30 days in accordance with the original prescription in order to ensure that therapy is not disrupted if he or she is satisfied that an authorised prescriber initiated the therapy, with the intention that the therapy be continued, and that the particulars of such sale are recorded in a prescription book or other prescribed permanent record;

(m) a pharmacist may sell a greater or a lesser quantity of a Schedule 1, Schedule 2, Schedule 3 or Schedule 4 substance than the quantity prescribed or ordered, according to the therapeutic pack in the original container of such substance as supplied to him or her, but the quantity so sold shall not exceed or be less than, 25 per cent of the quantity specified in the prescription or order in question;

(n) any seller referred to in this subsection shall retain the prescription or order concerned for a period of not less than five years as from the date of such sale;

(o) a Schedule 6 substance may only be sold if the course of treatment does not exceed 30 consecutive days;

(r) any Schedule 1, Schedule 2, Schedule 3 or Schedule 4 substance for the treatment of any animal may be supplied by any person practising a para-veterinary profession within the meaning of the Veterinary and Para-Veterinary Professions Act, 1982 (Act 19 of 1982), upon a written prescription issued by a veterinarian or on the verbal instructions of a veterinarian.

(9) (a) No person shall-

(i) acquire, use, possess, manufacture, or supply any Schedule 7 or Schedule 8 substance, or manufacture any specified Schedule 5 or Schedule 6 substance unless he or she has been issued with a permit by the Director-General for such acquisition, use, possession, manufacture, or supply: Provided that the Director-General may, subject to such conditions as he or she may determine, acquire or authorise the use of any Schedule 7 or Schedule 8 substance in order to provide a medical practitioner, analyst, researcher or veterinarian therewith on the prescribed conditions for the treatment or prevention of a medical condition in a particular patient, or for the purposes of education, analysis or research;

(ii) manufacture, use or supply any Schedule 5 or Schedule 6 substance for other than medicinal purposes, unless he or she has been issued by the Director-General with a permit for such manufacture, use or supply upon the prescribed conditions.

(b) Notwithstanding paragraph (a), the Director-General may at any time revoke any permit issued in terms of that paragraph if any condition on which the permit was issued is not being complied with.

(c) A permit issued in terms of this subsection shall be valid for a period of 12 calendar months after the date of issue thereof.

(10) Notwithstanding anything to the contrary contained in this section, no person shall sell or administer any Scheduled substance or medicine for other than medicinal purposes: Provided that the Minister may, subject to the conditions or requirements stated in such authority, authorise the administration outside any hospital of any Scheduled substance or medicine for the satisfaction or relief of a habit or craving to the person referred to in such authority.

(12) (a) The control on the importation of Scheduled substances shall relate to-

(i) any specified Schedule 5, Schedule 6, Schedule 7 or Schedule 8 substance;

(ii) such substances irrespective of the scheduling status allocated thereto, as the Minister may prescribe;

(iii) any other substance which becomes subject to international control in terms of the 1961 Single Convention on Narcotic Drugs or the 1971 Convention on Psychotropic Substances entered into by the Republic.

(b) The obtaining of import or export permits as required in terms of subsection (11) shall not apply to any preparation which contains a substance as prescribed which is specifically exempted from all control measures for the obtaining of such import or export permits by the 1961 Single Convention on Narcotic Drugs referred to in paragraph (a).

(c) Notwithstanding paragraph (b), no such importation or exportation shall take place unless authorised by the Director-General.

(13) Any permit issued under subsection (11) shall be subject-

(a) to the applicant's furnishing the registrar annually with the prescribed information;

(b) to the requirement that there shall be no deviation from the particulars reflected on the permit: Provided that if the quantity of such substance or medicine to be imported is less than that provided for in the permit, the Director-General shall be informed in writing thereof within 10 days after the importation of such substance or medicine; and

(c) to the conditions, as detailed on the permit, having been complied with, the triplicate copy of the permit having been certified by a customs officer or an employee of the S.A. Post Office Limited.

(14) Notwithstanding anything to the contrary contained in this section-

(a) a pharmacist's assistant shall not handle any specified Schedule 5 or Schedule 6 substance except as contemplated in subsection (5) (a) and (b); and

(b) no nurse or a person registered under the Health Professions Act, 1974, other than a medical practitioner or dentist, may prescribe a medicine or Scheduled substance unless he or she has been authorised to do so by his or her professional council concerned.

(15) Notwithstanding anything to the contrary contained in this section, the Director-General may, after consultation with the Interim Pharmacy Council of South Africa as referred to in section 2 of the Pharmacy Act, 1974 (Act 53 of 1974), issue a permit to any person or organisation performing a health service, authorising such person or organisation to acquire, possess, use or supply any specified Schedule 1, Schedule 2, Schedule 3, Schedule 4 or Schedule 5 substance, and such permit shall be subject to such conditions as the Director-General may determine.

(16) Notwithstanding anything to the contrary contained in this section-

(a) any person may possess a Schedule 0, Schedule 1 or Schedule 2 substance for medicinal purposes;

(b) any person may possess a Schedule 3, Schedule 4, Schedule 5 or Schedule 6 substance if he or she is in possession of a prescription issued by an
(c)any medicine or scheduled substance may be possessed by a medical practitioner, dentist, veterinarian, practitioner, nurse or other person registered under the Health Professions Act, 1974, or under the Veterinary and Para-Veterinary Professions Act, 1982, for the purposes of administering it in accordance with his or her scope of practice;

(d) any medicine or scheduled substance may be possessed for sale by a pharmacist, a person licenced to own a pharmacy in terms of the Pharmacy Act, 1974, or a person who is the holder of a licence as contemplated in section 22C.

(17) For the purposes of this section-

(a) 'authorised prescriber' means a medical practitioner, dentist, veterinarian, practitioner, nurse or other person registered under the Health Professions Act, 1974; and

(b) 'medicinal purpose' means for the purposes of the treatment or prevention of a disease or some other definite curative or therapeutic purpose, but does not include the satisfaction or relief of a habit or craving for the substance used or for any other such substance, except where the substance is administered or used in a hospital or similar institution maintained wholly or partly by the Government or a provincial government or approved for such purpose by the Minister.

22B Publication of information relating to medicine, Scheduled substance or medical device

(1) Notwithstanding the provisions of section 34 the council may, if it deems it expedient and in the public interest, disclose information in respect of the prescribing, dispensing, administration and use of a medicine, Scheduled substance or medical device.

(2) The Director-General may publish the information referred to in subsection (1) or release it to the public in a manner which he thinks fit.

22C. Licensing

(1) Subject to the provisions of this section-

(a) the Director-General may on application in the prescribed manner and on payment of the prescribed fee issue to a medical practitioner, dentist, practitioner, nurse or other person registered under the Health Professions Act, 1974, a licence to compound and dispense medicines, on the prescribed conditions;

(b) the council may, on application in the prescribed manner and on payment of the prescribed fee, issue to a manufacturer, wholesaler or distributor of a medicine or medical device a licence to manufacture, import or export, act as a wholesaler of or distribute, as the case may be, such medicine or medical device, upon such conditions as to the application of such acceptable quality assurance principles and good manufacturing and distribution practices as the council may determine.

(2) A licence referred to in subsection (1) (a) shall not be issued unless the applicant has successfully completed a supplementary course determined by the South African Pharmacy Council after consultation with the Health Professions Council of South Africa, the Allied Health Professions Council of South Africa and the South African Nursing Council.

(3) The Director-General or the council, as the case may be, may require an applicant contemplated in subsection (1) to furnish such information, in addition to any information furnished by the applicant in terms of the said subsection, as the Director-General or the council may deem necessary.

(4) When the Director-General or the council, as the case may be, grants or refuses an application for a licence-

(a) written notice shall be given of that fact to the applicant; and

(b) in the event of the refusal of an application, the applicant shall be furnished with the reasons for such refusal.

(5) No person shall compound or dispense a medicine unless he or she is authorised thereto in terms of the Pharmacy Act, 1974, is a veterinarian or is the holder of a licence as contemplated in subsection (1) (a).

(6) No manufacturer, wholesaler or distributer referred to in subsection (1) (b) shall manufacture, import, export, act as a wholesaler of or distribute, as the case may be, any medicine unless he or she is the holder of a licence contemplated in the said subsection.

(7) Subsections (5) and (6) shall come into operation twelve months from the date of commencement of this section.

22F Generic substitution

(1) Subject to subsections (2), (3) and (4), a pharmacist or a person licensed in terms of section 22C(1)(a) shall-

(a) inform all members of the public who visit the pharmacy or any other place where dispensing takes place, as the case may be, with a prescription for dispensing, of the benefits of the substitution for a branded medicine by an interchangeable multi-source medicine, and shall, in the case of a substitution, take reasonable steps to inform the person who prescribed the medicine of such substitution; and

(b) dispense an interchangeable multi-source medicine instead of the medicine prescribed by a medical practitioner, dentist, practitioner, nurse or other person registered under the Health Professions Act, 1974, unless expressly forbidden by the patient to do so.

(2) If a pharmacist is forbidden as contemplated in subsection (1) (b), that fact shall be noted by the pharmacist on the prescription.

(3) When an interchangeable multi-source medicine is dispensed by a pharmacist he or she shall note the brand name or where no such brand name exists, the name of the manufacturer of that interchangeable multi-source medicine in the prescription book.

(4) A pharmacist shall not sell an interchangeable multi-source medicine-

(a) if the person prescribing the medicine has written in his or her own hand on the prescription the words 'no substitution' next to the item prescribed;

(b) if the retail price of the interchangeable multi-source medicine is higher than that of the prescribed medicine; or

(c) where the product has been declared not substitutable by the council.

22G Pricing committee

(1) The Minister shall appoint, for a period not exceding five years, such persons as he or she may deem fit to be members of a committee to be known as the pricing committee.

(2) The Minister may, on the recommendation of the pricing committee, make regulations-

(a) on the introduction of a transparent pricing system for all medicines and Scheduled substances sold in the Republic;
(b) on an appropriate dispensing fee to be charged by a pharmacist or by a person licensed in terms of section 22C (1) (a).

(c) on an appropriate fee to be charged by wholesalers or distributors or any other person selling Schedule O medicines.

(3) (a) The transparent pricing system contemplated in subsection (2) (a) shall include a single exit price which shall be published as prescribed, and such price shall be the only price at which manufacturers shall sell medicines and Scheduled substances to any person other than the State.

(b) No pharmacist or person licensed in terms of section 22C (1) (a) or wholesaler or distributor shall sell a medicine at a price higher than the price contemplated in paragraph (a).

(c) Paragraph (b) shall not be construed as preventing a pharmacist or person licensed in terms of this Act to charge a dispensing fee as contemplated in subsection (2) (b).

(4) To the members of the pricing committee who are not in the full-time employment of the State may be paid such remuneration and allowances as the Minister, with the concurrence of the Minister of Finance, may determine.

23. Disposal of undesirable medicines

(1) If the council is of the opinion that it is not in the public interest that any medicine shall be made available to the public, it may-

(a) by notice in writing transmitted by registered post to any person direct that person; or

(b) by notice in the Gazette direct any person,

to return any quantity of such medicine which he has in his possession to the manufacturer thereof or (in the case of any imported medicine) to the importer concerned or to deliver or send it to any other person designated by the council.

(2) The council may by notice in writing direct any manufacturer or importer of any such medicine who has in his possession any quantity thereof (including any quantity returned, delivered or sent to him in pursuance of a direction under sub-section (1)), or any other person to whom any quantity of such medicine has been so returned, delivered or sent, to deal with or dispose of that quantity in such manner as the council may determine.

(3) No person shall sell any medicine which is the subject of a notice under subsection (1) which has not been set aside on appeal.

28. Powers of inspectors

(1) An inspector may at all reasonable times-

(a) enter upon-

(i)any place or premises from which-

(aa) a person authorised under this Act to compound and dispense medicines or scheduled substances;
(bb) the holder of a licence as contemplated in section 22C (1) (b);

(cc) the holder of a certificate of registration of a medicine, conduct business.

(ii) any place, premises, vessel or aircraft if he or she suspects on reasonable grounds that an offence in terms of this Act has been or is being committed thereon or therein or that an attempt has been made or is being made to commit such an offence thereon or therein;

(iii) any private dwelling, with the consent of the occupier or under the authority of a warrant

issued in terms of subsection (5) or without a warrant in terms of subsection (6);

(b) inspect any medicine or Scheduled substance, any book, record or documents that the inspector believes on reasonable grounds contains any information relevant to the administration or enforcement of this Act;

(c) seize any book, record, documents or medicine or scheduled substance or take so many samples of any such medicine or scheduled substance as he or she may consider necessary for the purpose of testing, examination or analysis in terms of this Act;

(2) Any sample taken in terms of paragraph (d) of subsection (1) shall be taken in accordance with the prescribed methods and in the presence of the person who is in charge of such medicine or Scheduled substance, or if there is no such person or if he is absent for any reason, in the presence of any other witness, shall forthwith be packed and sealed and suitably labelled or marked in such manner as its nature may permit and shall then be transmitted to an analyst, pharmacologist or pathologist together with a certificate in the prescribed form signed by such inspector and a copy of the aforesaid certificate shall be handed or transmitted by registered post to the owner or seller of such medicine or Scheduled substance or his agent.

(3) The analyst, pharmacologist or pathologist to whom a sample has been transmitted in terms of the provisions of subsection (2) shall with all convenient speed test, examine or analyse the sample delivered to him, and the result of the test, examination or analysis shall be stated in a certificate in the prescribed form.

(4) The owner of the medicine or Scheduled substance from which the sample was taken may claim from the Director-General an amount equal to the market value thereof.

(5) Where on application to a magistrate it appears to such magistrate from information on oath that there are

reasonable grounds to believe that-

(a) the conditions for entry described in subsection (1)(a) exist in relation to a private dwelling;

(b) entry to that private dwelling is necessary for any purpose relating to the administration or enforcement of this Act; and

(c) entry to the private dwelling has been refused or that entry thereto will be refused,

a magistrate may issue a warrant authorizing the inspector named therein to enter that private dwelling subject to such conditions as may be specified in the warrant

(6) If an inspector believes on reasonable grounds that-

(a) a warrant would be issued to him or her under subsection (5) if he or she applies for such warrant; and

(b) a delay in obtaining such warrant would defeat the object of the entry, search and seizure,

he or she may without a warrant enter and search any premises for any medicines, scheduled substance, book, record or document relevant to the administration or enforcement of this Act and seize or take samples as contemplated in subsection (1)(c).

36A Minister may prohibit the manufacture, sale or use of certain veterinary medicines

Notwithstanding anything to the contrary in this Act or in any other law contained, the Minister may by notice in the Gazette for any reason other than the safety, quality or therapeutic efficacy of a veterinary medicine-

(a) prohibit the manufacture, sale or use of any veterinary medicine containing a substance mentioned in the notice; or

(b) prohibit such manufacture, sale or use, except in accordance with such conditions as may be specified in the notice,

and may in like manner repeal or amend such notice.

Fertilizer, Farm Feeds, Agricultural remedies and Stock remedies Act, 1947 (Act No. 36 of 1947)

Regulations regarding Stock remedies published on 29 September 2006, Government Gazette No 29241.

All the regulations appear after the two extracts of particular importance to the Veterinary Profession.

Part II

" Labelling of containers

11. (1)     No person may sell any stock remedy without an approved label.

(2)    A container of a stock remedy shall not be labelled with any marks or signs other than the prescribed details in the labelling requirements, or in terms of a provision of any law, or and which was approved by the registrar.

(3)    Despite the labelling requirements in annexure D and regulations (10), and subject to the provisions of any other law, no words or marks may appear on the container in which a stock remedy is sold, or on a label and/or pamphlet affixed thereto without prior approval of the Registrar.

(4)    Only recognized chemical, analytical and pharmaceutical expressions or terms or those expressions or terms which, for reasons of clarity, have been approved by the Registrar, may be marked or printed on a container in which a registered stock remedy is sold, or on a label affixed thereto, for the purpose of explaining the composition of such remedy.

(5)    Approval of labelling by Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, (Act No. 36 of 1947) does not absolve the company from the obligations of complying with the South African National Standards 289 or any other relevant legislation.

Copies of the Labelling requirements for the registration of Stock Remedies under Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947) as per Annexure D of the regulations can be obtained from the administration of the SAVC or from the National Department of Agriculture.

Part III

Publication or distribution of false or misleading advertisements

12.    No person shall publish or distribute any false or misleading advertisement relating to stock remedy.

Details of advertisements

13.    (1) An advertisement shall when published in a newspaper, magazine or other printed matter:

(a)    furnish the trade mark, if any, and the trade name of the stock remedy;

(b)    where it is applicable furnish the hazard statement;

(c)    indicate the name of the active ingredient which it contains;

(d)    contain the registration number of the stock remedy in question with a reference to the Act, expressed as " Reg. No. ...........Act 36 /1947"; and

(e)    furnish the name and address of the registration holder.

(2) An advertisement shall, when screened or broadcast, at least furnish those details referred to  in sub-regulation (1) (a) and (d).

(3) Any reference in an advertisement to:

(a)    an active ingredient;

(b)    the instructions for use, claims, application or administration; and

(c)    the registration, of the stock remedy in question shall:

correspond to those details approved on the label or be based on the data filed in support of the application for the registration of the stock remedy being advertised.

(4) Any statement made in an advertisement must be scientifically verifiable and on request of the Registrar such verification must be provided to the Registrar.

(5) All advertisements must comply with the prescriptions for advertising of the Advertising Standards Authority of South Africa.

Approval of advertisements

14.    (1) No advertisement shall be published, screened or broadcast without prior approval of the Registrar.

(2) Approval of advertisements by  Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, (Act No. 36 of 1947) is based on the Stock Remedies Regulations of Act No. 36 of 1947 and therefore does not absolve the company from the obligations of complying with the prescriptions for Advertising Standards Authority of South Africa or any other relevant legislation."


GNR.956 of 29 September 2006:  Regulations regarding stock remedies

DEPARTMENT OF AGRICULTURE

I, Lulama Xingwana, acting under section 23 of the Fertilizer, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act No. 36 of 1947), made the regulations in the Annexure hereto.

L. Xingwana

Minister of Agriculture.

SCHEDULE

ARRANGEMENT OF SECTIONS

1.
Definitions

PART I
REGISTRATION

2.
Application for registration

3.
Period of registration

4.
Suitability and efficacy of stock remedies

5.
Renewal of registration

6.
Conditions for renewal and registration amendments of certain registrations

7.
Application for amendment of certain registrations and approved labels

8.
Application for transfer of a registration

9.
Return of certificate of registration

PART II
LABELLING AND CONTAINERS

10.
Containers of stock remedies

11.
Labelling of containers

PART III
ADVERTISEMENTS

12.
Publication or distribution of false or misleading advertisements

13.
Details of advertisements

14.
Approval of advertisements

PART IV
MANUFACTURING ESTABLISHMENTS

15.
Manufacturing Facilities

16.
Requirements for establishments

17.
Records at establishments

PART V
SAMPLING AND PERMISSIBLE DEVIATIONS

18.
Sampling of stock remedies

19.
Permissible deviations in active ingredient contents

PART VI
HANDLING, STORAGE AND DISPOSAL OF STOCK REMEDIES

20.
Handling of Group I Stock Remedies

21.
Handling, storage and disposal

PART VII
IMPORTS

22.
Importation of Stock Remedies

23.
Harbours and places through which imports may be made

PART VIII
APPEALS

24.
Submission of appeals

25.
Address for submission of appeals

PART IX
GENERAL

26.
Offences and penalties

27.
Payment of fees

28.
Address for submission of documents

29.
Amendment and repeal of certain regulations

Annexure A

Application for: The Registration of a Stock Remedy or Amendment of the registration of a Stock Remedy (SRA01)

Annexure B

Table 1: Payable Fees

Annexure C

Data Requirements for the Registration of Stock Remedies

Annexure D

Labeling Requirements for the Registration of Stock Remedies

Annexure E

Ports of Entry

Annexure F

Certificate in respect of the taking of samples in terms of section 15 of Act No. 36 of 1947

Annexure G

Certificate of Results of Analyses or Test of a Sample of Stock Remedies by Analyst

1.   Definitions.—In these regulations, unless inconsistent with the context—

“applicant” means the person in whose name an application for the registration of a stock remedy has been filed;

“invoice” means also an accompanying letter, delivery note or weighbridge ticket, receipt note or receipt;

“label” means any written, printed or graphic representation attached to or included in a container of a stock remedy;

“manufacture” means make, compound, mix, formulate, process, package and label for purpose of sale and, “manufacturing” and “manufacturing process” have a similar meaning;

“manufacturer” means an individual or undertaking that manufactures stock remedies;

“registered name” means the name approved by the registrar under which a stock remedy is registered and may be sold;

“registration holder” means the person to whom a certificate of registration in respect of a particular stock remedy has been issued;

“SANS” means South African National Standards;

“sworn translator” means a person admitted and enrolled by any division of the Supreme Court (High Court) in terms of Rule 59 of the Rules of Superior Court Practice.

“trademark” means a mark to which the holder of the registration has the right, either as owner or a registered user thereof, to distinguish his/her stock remedy from that of any other manufacturer but excludes the registered name of a stock remedy as intended in these regulations;


PART I
REGISTRATION

2.   Application for registration.—(1)  An application in terms of section 3 (1) of the Act, for the registration of a stock remedy, must be submitted in triplicate to the Registrar on a prescribed form as set out in Annexure A.

(2)  An application must only be made by a person who is resident in the Republic or, in the case of a juristic person, who has a registered office in the Republic.

(3)  An application shall be accompanied by:

(a)       the prescribed application fee as set out in Annexure B, Table 1;

(b)       three copies of a typed label, in English. If any other language is used the label shall also be submitted in triplicate with an affidavit from the sworn translator declaring the label to be a true translation of the English label;

(c)        a copy of the required data that substantiate and support the safety, quality and efficacy of the stock remedy as outlined in the data requirements set out in Annexure C. Data on biological efficacy of the stock remedy concerned must be determined under South African conditions.

(4)  the Registrar may request additional data or sample which may enable him to evaluate the application.

(5)  In the case of a stock remedy of which the active ingredient and formulation is identical to that of a stock remedy which is registered in favour of another registration holder, further be accompanied by the declaration by such other registration holder that the stock remedy in respect of which the application for registration is made may be registered in favour of the applicant concerned.

3.   Period of registration.—Subject to the provisions of sections 3 (4) (a) and 4A of the Act a registration will be valid for one year from the date of registration.

4.   Suitability and efficacy of stock remedies.—(1)  The suitability and efficacy of a stock remedy shall be proved by results of trials by the applicant or on behalf of the applicant or by a competent body which is recognized for this purpose.

(2)  The person or body referred to in sub-regulation (1) shall, prior to the commencement of a trial in the Republic, request approval from the Registrar in writing of the intention to conduct such a trial, and the Registrar may inspect the performance of such a trial.

(3)  The Registrar may permit the use of an unregistered stock remedy for the purpose indicated in sub-regulation (1).

(4)  The Registrar may permit the import of an unregistered stock remedy for the purpose indicated in sub-regulation (1).

(5)  The Registrar may permit the use of a registered stock remedy contrary to label indications for the purpose indicated in sub-regulation (1).

5.   Renewal of registration.—(1)  An application in terms of section 3 (4) (a) of the Act for the renewal of a registration of a stock remedy, shall be submitted to the Registrar on a form which is obtainable from the Registrar for this purpose, or on a clearly legible facsimile thereof.

(2)  Such application shall:

(a)       be made by the registration holder;

(b)       be submitted to the Registrar on or before the expiry date of the registration concerned but not more than three months prior to such expiry date;

(c)        be accompanied by the prescribed renewal fee as outlined in Annexure B;

(d)       be accompanied by the current approved printed or scanned label.

(3)  An application made in terms of sub-regulation (1) which:

(a)       is received by the Registrar after the expiry date, but not more than 30 days after such expiry date, shall be considered only if it is accompanied by the prescribed maintenance fee for a late maintenance referred to in Annexure B;

(b)       which is received by the Registrar after the days of grace referred to in paragraph (a) expired, will not be considered. A new application must be made in terms of regulation 2.

(4)  Any person who applies in terms of this regulation for the renewal of a registration shall in an affidavit confirm that the details which he furnishes with such application in respect of the stock remedy concerned or of a label which is being used in connection therewith, do not deviate in any manner whatsoever from the congruent details which have already been registered or approved in relation to that stock remedy or label.

6.   Conditions for renewal and registration amendments of certain registrations.—A renewal of a registration and the registration amendment of a stock remedy under section 3 of the Act are granted on condition that during the period of registration, amendment or renewal of the registration:

(a)       the formulation of the stock remedy concerned shall not deviate from the formulation which is registered in respect thereof;

(b)       the details which are approved to be indicated on a label or container used in connection with the sale of the stock remedy concerned, shall not be altered without the prior written approval of the Registrar;

(c)        that the details of the manufacturer of the active ingredient/s and the manufactured product shall not differ from the approved details; and

(d)       all conditions determined by the Registrar are met.

7.   Application for amendment of certain registrations and approved labels.—(1)  If any person in whose name a stock remedy is registered, intends to amend any detail relating thereof; he shall apply for an amendment to the registration on a form set out in Annexure A or on a clearly legible facsimile thereof.

(2)  An application for an amendment shall:

(a)       be made by the current registration holder;

(b)       be accompanied by the prescribed application fee as set out in Annexure B;

(c)        be accompanied by a typed label in triplicate in English and any other official language with an affidavit from the sworn translator declaring the label to be a true translation of the English label, if the amendment will affect any change to the label;

(d)       be accompanied by a certified copy of the current certificate of registration and an undertaking to deliver the original thereof to the Registrar immediately upon the allowance of amendment, if the amendment will affect any changes to the certificate;

(e)       be accompanied by the relevant data as stipulated in data requirements set out in Annexure C if the data has not previously been submitted to the Registrar.

Provided that the Registrar may grant exemption from the payment of the application fee concerned if the alteration or amendment concerned:

(a)       is in the public interest; or

(b)       is effected by the Registrar.

8.   Application for transfer of a registration.—(1)  An application for transfer of registration shall be made by, a person who is resident in the Republic or, in the case of a juristic person, who has a registered office in the Republic.

(2)  Such application shall be accompanied by:

(a)       the prescribed application/registration fee as set out in Annexure B;

(b)       the copy of the current registration certificate of the stock remedy to be transferred, if it has not already been submitted;

(c)        a written consent from the current registration holder of the stock remedy authorizing the transfer of the registration;

(d)       a declaration from the applicant confirming that the particulars furnished in the application and the label in connection therewith, remains identical to those of the registered or approved stock remedy except the details of the registration holder.

9.   Return of certificate of registration.—A certificate of registration which is returned in terms of section 4A (3) of the Act shall reach the Registrar:

(a)       within 14 days of the date on which:

(i)         the person to whom the certificate of registration in question was issued, was notified in terms of section 5 of the Act in writing of the reasons for the cancellation of such registration; or

(ii)         the registration of the stock remedy, concerned has lapsed in terms of section 4A (2) of the Act, as the case may be; or

(b)       at least 30 days prior to the date on which the registration of stock remedy is to be transferred to another person: Provided that an application as contemplated in the regulation for the registration of the stock remedy in question in favour of such other person, shall be submitted simultaneously.


PART II
LABELLING AND CONTAINERS

10.   Containers of stock remedies.—(1)  Subject to the provisions of any other law relating to containers, a container in which a quantity of a stock remedy is packed for sale, shall at the time of packing:

(a)       be sound and clean;

(b)       be closed or sealed in the manner permitted by the stock remedy

(2)  The design of the container shall:

(a)       after the contents thereof has been used not be instrumental to the use of such empty container or sachet for any other purpose;

(b)       in the case of a liquid stock remedy, prevent spillage when pouring out the contents thereof.

(3)  A stock remedy shall not be sold in a container/packaging which was not approved by the Registrar and if appropriate approved in terms of a provision of any other law.

11.   Labelling of containers.—(1)  No person may sell any stock remedy without an approved label.

(2)  A container of a stock remedy shall not be labelled with any marks or signs other than the prescribed details in the labelling requirements, or in terms of a provision of any other law, or and which was approved by the Registrar.

(3)  Despite the labelling requirements in annexure D and regulations (10), and subject to the provisions of any other law, no words or marks may appear on the container in which a registered stock remedy is sold, or on a label and/or pamphlet affixed thereto without prior approval of the Registrar.

(4)  Only recognized chemical, analytical and pharmaceutical expressions or terms or those expressions or terms which, for reasons of clarity, have been approved by the Registrar, may be marked or printed on a container in which a registered stock remedy is sold, or on a label affixed thereto, for the purpose of explaining the composition of such remedy.

(5)  Approval of labelling by Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, (Act No. 36 of 1947) does not absolve the company from the obligations of complying with the South African National Standards 289 or any other relevant legislation.


PART III
ADVERTISEMENTS

12.   Publication or distribution of false or misleading advertisements.—No person shall publish or distribute any false or misleading advertisement relating to a stock remedy.

13.   Details of advertisements.—(1)  An advertisement shall when published in a newspaper, magazine or other printed matter:

(a)       furnish the trade mark, if any, and the trade name of the stock remedy;

(b)       where it is applicable furnish the hazard statement;

(c)        indicate the name of the active ingredient which it contains;

(d)       contain the registration number of the stock remedy in question together with a reference to the Act, expressed as “Reg. No. ...... Act 36/1947”; and

(e)       furnish the name and address of the registration holder.

(2)  An advertisement shall, when screened or broadcast, at least furnish those details referred to in sub-regulation (1) (a) and (d).

(3)  Any reference in an advertisement to:

(a)       an active ingredient;

(b)       the instructions for use, claims, application or administration; and

(c)        the registration, of the stock remedy in question shall:

correspond to those details approved on the label or be based on the data filed in support of the application for registration of the stock remedy being advertised.

(4)  Any statements made in an advertisement must be scientifically verifiable and on request of the Registrar such verification must be provided to the Registrar.

(5)  All advertisements must comply with the prescriptions for advertising of the Advertising Standards Authority of South Africa.

14.   Approval of advertisements.—(1)  No advertisement shall be published screened or broadcast without prior approval of the Registrar.

(2)  Approval of advertisements by Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, (Act No. 36 of 1947) is based on the Stock Remedies Regulations of Act No. 36 of 1947 and therefore does not absolve the company from the obligations of complying with the prescriptions for Advertising Standards Authority of South Africa or any other relevant legislation.

 

PART IV
MANUFACTURING ESTABLISHMENTS

15.   Manufacturing Facilities.—(1)  The practices in respect of the operation of the undertaking at an establishment and which relates to the manufacture, control, packing, marking or labelling of a stock remedy for the purpose of sale, shall be in conformance with quality document management system and be such that the composition and efficacy of the stock remedy in question complies with the details registered in respect thereof, and that it possesses all the chemical, physical and other properties thus registered.

(2)  Raw materials used for the manufacture of a stock remedy, and the stock remedy manufactured there from, shall be handled and stored at the premises of an establishment in such manner that—

(a)       it is protected against damage, contamination and deterioration; and

(b)       access to the different raw materials and stock remedies can readily be obtained.

(3)  Chemical or physical quality checks shall be made on each consignment of all raw materials used for the manufacture of a stock remedy and on the stock remedy manufactured from such raw materials by the person in whose favour a stock remedy is registered or by a competent body which is recognized for this purpose.

(4)  An employee at an establishment who is responsible for the manufacture, control, packing, marking or labelling of a stock remedy shall have the knowledge of the practices to be followed in the operation of the undertaking of such establishment and of the provisions of the Act which, in the opinion of the Registrar, is sufficient for the performance of the duty imposed upon such employee.

(5)  The names of the raw materials to be used for the manufacture of a stock remedy shall be marked clearly and legibly on the containers thereof provided that if such raw materials are stored in bulk, the names of such raw materials shall be shown on the containers in or the places at which they are thus stored.

(6)  If a stock remedy is not packed and labelled immediately after manufacture, the name thereof shall be shown on the containers in or places at which it is stored.

16.   Requirements for establishments.—(1)  An establishment where a stock remedy is manufactured, controlled, packed or labelled for the purpose of sale, shall be registered under the Factories, Machinery and Building Work Act, 1941 (Act No. 22 of 1941

) and must conform to the requirements of the Occupational Health and Safety Act, 1993 (Act No. 85 of 1993).

(2)  The premises of such establishment shall be kept orderly and clean.

(3)  The area at such establishment which is used for the performance or a particular function in connection with the manufacture, control, packing or labelling of a stock remedy shall be adequate for the proper carrying out of that function.

(4)  Facilities and equipment which shall ensure that a stock remedy shall be manufactured, packed and labelled in the manner determined in these regulations and that the composition and efficacy of the stock remedy concerned complies with the requirements registered in respect thereof, and that it possesses the chemical, physical and other properties thus registered, shall be available at the establishment concerned;

(5)  The Registrar may publish additional guidelines for the requirements of establishments in the Government Gazette that must be adhered to.

17.   Records at establishments.—(1)  A person managing the undertaking at an establishment shall, in respect of each batch of the different stock remedies manufactured, controlled, packed or labelled there, keep comprehensive records of:

(a)       the results of quality checks which were made in terms of regulation 18 (3) of the raw materials used for the, manufacture of the stock remedy, comprising such batch, and of such stock remedy;

(b)       the total quantity of the stock remedy comprising such batch and if packed, the number of containers in which it is packed;

(c)        the names and addresses of the persons to whom the stock remedy was sold, and the quantity thereof which is sold to each such person;

(d)       complaints which were received in connection with the composition or efficacy of the stock remedy comprising such batch, or the chemical, physical or other properties thereof.

(2)  The records to be kept at an establishment in terms of sub-regulation (1) as well as the formula for formulating a batch of a stock remedy there shall be preserved at such establishment and for at least five years after the date on which the batch concerned was manufactured. In the case of raw materials after the date of first receipt provided that if a complaint referred to in sub-regulation (1) (d) was received, the records in respect of the batch in question shall not be destroyed within two years from the date of such complaint. Records must always be available at an establishment for inspection by the authority.

 

PART V
SAMPLING AND PERMISSIBLE DEVIATIONS

18.   Sampling of stock remedies.—(1)  A stock remedy which is sold in containers shall be sampled by selecting at different places from the stock of a particular stock remedy the number of containers required to obtain a statistically significant quantity for a sample of such a stock remedy:

(a)       Such containers shall be similarly labelled and the stock remedy therein shall originate from the same batch.

(b)       If a sample is composed of the contents of more than one container, such a sample shall be thoroughly mixed before being divided in terms of section 15 (3) (c) of the Act.

(c)        Despite the provisions of sub regulation (1) (a), at least three sealed containers in which a stock remedy is sold, may also be taken as the sample of such stock remedy and the containers comprising such sample shall, without being opened, be divided in terms of section 15 (3) (c) of the Act.

(2)  A stock remedy which is not sold in a container shall be sampled by taking small quantities at different places from the stock of such stock remedy to obtain a sufficient quantity for a sample. Such a sample shall be thoroughly mixed before being divided in terms of section 15 (3) (c) of the Act.

(3)  The provisions of sub regulation (2) shall mutatis mutandis apply to the sampling of a stock remedy referred to in sub regulation (1) prior to the packing thereof in containers, and the sampling of an active ingredient used in the manufacture of a stock remedy.

(4)  Where a stock remedy in a container is of a perishable nature, or where for any reason the opening of the container would interfere with the analysis of the remedy unless such analysis were effected at the time of opening or immediately thereafter, at least three containers, similarly labelled and purporting to contain a similar stock remedy, shall be procured. The containers thus procured shall be split up into three groups, each of which shall contain one or more unopened containers and which shall further be dealt with as prescribed by section 15 (2) of the Act.

(5)  A certificate which in terms of section 15 (4) (b) of the Act is forwarded to an analyst together with a sample of the stock remedy, shall be in the prescribed form. Annexure F.

(6)  A certificate on which the result of a test, examination or analysis of a sample of a stock remedy is to be recorded in terms of section 15 (4) (b) of the Act, shall be in a prescribed form. Annexure G.

(7)  That part of a sample of a stock remedy which is referred to in section 15 (4) (c) of the Act:

(a)       shall, if a certificate referred to in sub regulation (5) indicates that such sample does not possess the chemical, physical or other properties specified in the application for registration of the stock remedy concerned, or does not comply with any requirements referred to in these regulations, be retained until the action arising from such certificate is concluded;

(b)       may otherwise be destroyed.

19.   Permissible deviations in active ingredient contents.—Despite anything to the contrary contained in these regulations, a stock remedy shall not be deemed to deviate in its registered active ingredient contents if a certificate referred to in regulation 18 (5) in relation to the analysis of a sample of such a stock remedy indicates that the active ingredient concentration is within 10 % of the registered label claim, when the product is within its shelf life, and stored as instructed.


PART VI
HANDLING, STORAGE AND DISPOSAL OF STOCK REMEDIES

20.   Handling of Group I Stock Remedies.—Any person in control of an establishment selling, supplying or making available danger group I stock remedies must be licensed in terms of the regulations promulgated in terms of the Hazardous Substances Act, 1973 (Act No. 15 of 1973), comply with the conditions of sale or supply of Group I hazardous substances and keep such records as required.

21.   Handling, storage and disposal.—All requirements with regard to South African National Standards must be complied with.


PART VII
IMPORTS

22.   Importation of Stock Remedies.—No person shall import a stock remedy into the Republic unless such remedy is registered: Provided that the Registrar may permit, in writing, the importations into the Republic of a specified quantity of a stock remedy which is not registered for purposes of experimentation or for some purpose other than the sale of such remedy.

23.   Harbours and places through which imports may be made.—Stock remedies may only be imported through the ports of entry as outlined in Annexure E.


PART VIII
APPEALS

24.   Submission of appeals.—(1)  An appeal in terms of section 6 of the Act shall be submitted to the Minister by delivering the documentation to the Director-General: Agriculture within 60 days of the date on which the reasons for the decision against which is appealed, were furnished in terms of section 5 of the Act.

(2)  Such appeal shall:

(a)       be in the form of a written statement which is sworn to or attested;

(b)       state the reference number and date of the document by means of which such applicant or person was given notice of that decision;

(c)        state the grounds on which the appeal is based;

(d)       be accompanied by the documents relating to the subject of the appeal; and

(e)       be accompanied by the fee as Outlined in Annexure B.

(3)  If such appeal is submitted by a person other than the person in respect of whom the decision concerned was furnished, the appeal concerned shall be accompanied by a statement in which the person concerned discloses interest in that decision or action.

(4)  The amount referred to in sub regulation (2) (e) shall be paid by cheque, postal order or money order made out in favour of the Director-General: Agriculture: Provided that if the appeal concerned is delivered by hand, such amount may be paid in cash.

25.   Address for submission of appeals.—An appeal referred to in regulation 24 (1) shall:

(1)  when forwarded by post, be addressed to the Director-General, Department of Agriculture, Private Bag X 250, Pretoria, 0001; and

(2)  when delivered by hand, be delivered to the Director-General, Department of Agriculture, Agriculture Building , 20 Beatrix Street , Pretoria .


PART IX
GENERAL

26.   Offences and penalties.—Any person who refuses or fails to comply with the provisions of these regulations shall be guilty of an offence and liable on conviction to a fine or imprisonment or to both a fine and imprisonment. The fine will be determined by the Adjustment of Fines Act, 1991 (Act No.101 of 1991).

27.   Payment of fees.—(1)  The postage on and delivery costs of any application or document submitted in terms of these regulations, as well as on or of anything else pertaining thereto, shall be paid by the consigner.

(2)  Any fee payable in terms of these regulations shall be paid by means of a cheque, postal order or money order made out in favour of the Director-General: Agriculture: Provided that if such fee is delivered by hand, it may be paid in cash.

(3)  Fees which are paid in terms of these regulations shall subject to section 6 of the Act, not be refundable.

28.   Address for submission of documents.—Any application or document or anything else pertaining thereto, which is required in terms of these regulations to be submitted to the Registrar shall:

(1)  when forwarded by post, be addressed to:

The Registrar: Act No. 36 of 1947, Private Bag X 343, Pretoria , 0001; and

(2)  when forwarded by rail or delivered by hand, be addressed or delivered to:

The Registrar: Act No. 36 of 1947, Agriculture Building , 20 Beatrix Street , Pretoria .

29.   Amendment and repeal of certain regulations.—The following regulations are hereby repealed:

(1)  The Regulations relating to Stock Remedies published under Government Gazette Notice No. R857 of 28 May 1971 and;

(2)  The Regulations relating to Stock Remedies published under Government Notice No. R. 1449 of 1 July 1983.A

No. R. 864      1 September 2006

ANIMAL DISEASES ACT, 1984 (ACT No. 35 OF 1984)

REGULATIONS: AMENDMENT

I, Lulama Xingwana, Minister of Agriculture, acting under section 31 of the Animal Diseases Act, 1984 (Act No. 35 of 1984), hereby make the regulation hereunder.

Lulama Xingwana

Minister of Agriculture

SCHEDULE

Definitions

1.In this Schedule any word or phrase to which a meaning has been assigned in the Act, shall have that meaning and unless the context otherwise indicates -

"the Act", means the Animal Diseases Act, 1984 (Act No. 35 of 1984); and

"the Regulations", means the Animal Diseases Regulations as published by Government Notice No. R. 2026 of 26 September 1986, as amended by Government Notices Nos. R. 2208 of 24 October 1986, R.266 of 13 February 1987, R. 2343 of 16 October 1987, R.884 of 5 May 1988 (as corrected by Government Notice No. R. 1043 of 3 June 1988), R. 394 of 1 March 1991 (as corrected by Government Notice No. R. 931 of 3 May 1991), R.2358 of 10 December 1993, R.1023 of 27 May 1994, R. 254 of 6 February 1997, R.1136 of 11 September 1998, R.361 of 7 April 2000, R. 443 of 25 May 2001, R. 885 of 21 September 2001 (as corrected by Government Notice No. R. 1386 of 21 December 2001), R. 162 of 24 February 2006, R. 163 of 24 February 2006, and R. 338 of 7 April 2006.

Amendment of regulation 20 of the Regulations

2.Regulation 20 of the Regulations is hereby amended by-

(a) the substitution of subparagraph (v) of paragraph (a) of subregulation (1) by the following subparagraph:

"(v) move or remove live buffalo, warthogs, bush pigs, wild pigs and ostriches from the land on which they are kept to any other land;";

(b) the substitution of subregulation (4) by the following subregulation:

"(4) A permit referred to in subregulation (1) for the movement of ostriches shall be issued only if the land to which those ostriches are to be moved or removed are registered as contemplated in regulation 20C."

(c) the insertion of the following subregulation after subregulation (4):

"(5) The director may by notice in a newspaper in the manner contemplated in regulation 2 (1) (a) or by means of a circular, and if he is satisfied by the circumstances in a controlled area that the achievement of a controlled purpose will not be defeated thereby, exempt the responsible persons in a particular controlled area or a portion of such area from the provisions of subregulations (1) and (3) and (4)."

Insertion of regulation 20C of the Animal Diseases Regulations

3. The following regulation is hereby inserted after regulation 20B of the Animal Diseases Regulations:

"20C. (1) No person shall keep ostriches on any land which is not registered by the director for this purpose.

(2) An application for the registration of land for the keeping of ostriches shall:

(a) be made by the responsible person in charge of the land concerned on the applicable forms, which are obtainable from the office of the responsible State Veterinarian; and

(b) be handed in at the office of the responsible State Veterinarian.

(3) Land for the keeping of ostriches shall only be registered if the responsible person complies with relevant disease control, testing, traceability and biosecurity measures to the satisfaction of the director."

Lulama Xingwana

Minister of Agriculture

No. R. 543      6 July 2007

(Government Gazette 30023)

ANIMAL DISEASES ACT, 1984
(ACT No. 35 OF 1984)

ANIMAL DISEASES REGULATIONS: AMENDMENT

The Minister of Agriculture has under Section 31 of the Animal Diseases Act, 1984 (Act No. 35 of 1984), made the regulations in the Schedule.

SCHEDULE

Definitions

1. In this Schedule "the Regulations" means the regulations published by Government Notice No. R. 2026 of 26 September 1986, as amended by Government Notices Nos. R. 2208 of 24 October 1986, R. 266 of 13 February 1987, R. 2343 of 16 October 1987, R. 884 of 5 May 1988 (as corrected by Government Notice No. R. 1043 of 3 June 1988), R. 394 of 1 March 1991 (as corrected by Government Notice No. R. 931 of 3 May 1991), R. 2358 of 10 December 1993, R. 1023 of 27 May 1994, R. 254 of 6 February 1997, R. 1136 of 11 September 1998, R. 361 of 7 April 2000, R. 443 of 25 May 2001, R. 885 of 21 September 2001 (as corrected by Government Notice No. R. 1386 of 21 December 2001), R. 162 of 24 February 2006, R. 163 of 24 February 2006 and R. 864 of 1 September 2006 (as corrected by Government Notice No. R. 1059 of 27 October 2006).

Amendment of regulation 24 of the Regulations

2 Regulation 24 of the Regulations is hereby amended by the substitution of paragraph (e) by the following paragraph:

"feed any protein of ruminant origin (except milk and milk products) to any animals other than predators and carnivores."

Amendment of Table 2 of the Regulations

3 Table 2 of the Regulations is hereby amended by the substitution of the entry in column 4 opposite the controlled animal disease "Bovine Spongiform encephalopathy" and the controlled animal disease "Scrapie":

"No person shall feed any protein of ruminant origin (except milk and milk products) to any animals other than predators and carnivores."

To: South African Veterinary Council

Scroll Down for the Afrikaans version "Verklaring"

I, the undersigned

____________________________________________

[please refer to note 1]

hereby make oath and state/ solemnly affirm that:

[please refer to note 2]

1.

The facts as stated within this affidavit are within my personal knowledge, and are true and correct.

[please refer to note 3]

2.

I am an adult person and ..............

please refer to note 4]

3.

I wish to bring the complaint as set out below to the attention of the South African Veterinary Council.

4.

[please refer to note 5]

[please refer to note 6]

_____________________________________

DEPONENT

THUS SIGNED AND SWORN TO BEFORE ME AT…………………………...........

THIS .…….......DAY OF ....................…………........... 2015,

THE DEPONENT HAVING ACKNOWLEDGED THAT HE/SHE* KNOWS AND UNDERSTANDS THE CONTENTS OF THIS AFFIDAVIT, THAT HE/SHE* HAS NO OBJECTION TO TAKING THE PRESCRIBED OATH AND THAT HE/SHE* CONSIDERS THE PRESCRIBED OATH/SOLEMN AFFIRMATION* TO BE BINDING ON HIS/HER* CONSCIENCE, AS REQUIRED BY GOVERNMENT GAZETTE NOS. R1258 OF 21 JULY 1972 AND R1648 OF 19 AUGUST 1977.

___________________________________

COMMISSIONER OF OATHS

_____________________________________________

FULL NAME AND SURNAME OF COMMISSIONER

(IN BLOCK LETTERS)

_____________________________________________________________________

BUSINESS ADDRESS OF COMMISSIONER

_________________________

DESIGNATION

_________________________

AREA

NOTES TO THE AFFIDAVIT

Note 1: Please provide your full names.

Note 2: Affidavits may be in the form of either a sworn statement or a solemn affirmation. Please select the form you prefer by deleting the alternate option here as well as within the text of your declaration before the Commissioner of Oaths at the end of your affidavit.

Note 3: Please take particular care that the information that you provide is a fair reflection on what really happened.

Please also take particular care that this information is really within your personal knowledge, that is that you personally experienced these facts with your own five senses. For example, you must have personally spoken to the vet about that aspect or you must have personally seen or heard the alleged fact yourself. If you are basing any of your allegations on someone else’s personal knowledge, then that person must provide a Confirmatory Affidavit to state that your allegations that pertain to them are true. (An example of such a Confirmatory Affidavit has been included at the end.)

If your affidavit would be based largely or completely on another person’s experiences, then that person should make the affidavit. If some of the facts contained in this other person’s affidavit are within your knowledge only, then that person would be entitled to make those statements in his or her affidavit, provided that person attaches a confirmatory affidavit from you.

Note 4: Please set out your relationship to the animal or how the event occurred on which your complaint is based.

Note 5: Please set out your complaint or complaints in this paragraph and the successive paragraphs. Please use separate consecutively numbered paragraphs for each allegation, using as many paragraphs as you need.

Your affidavit will have more impact if you are able to clearly set out the facts on which your allegations are based in an objective way.

It would be very helpful if you summarised your complaints by setting them out once again in point form in the last paragraph.

Note 6: When you have fully set out your complaint as suggested above, you must attach this second page to the back of your complaint. Then take the whole document to a Commissioner of Oaths, and sign your name on the line identified as "DEPONENT" before the Commissioner, who will then complete the rest of the page.

You will find Commissioners of Oaths at your local police station. Attorneys, bank managers and post masters are also Commissioners of Oaths.

Should you require any further information, you are welcome to contact the SA Veterinary Council at 012-345 6347, Fax 012-345 6369 or e-mail This email address is being protected from spambots. You need JavaScript enabled to view it. .

CONFIRMATORY AFFIDAVIT

I, the undersigned

____________________________________________

[please refer to note 1]

do hereby make oath and state/ solemnly affirm that:

[please refer to note 2]

1.

The facts as stated within this affidavit are within my personal knowledge, and are true and correct.

[please refer to note 3]

2.

I am an adult person and ..............

please refer to note 4]

3.

I have read the attached Affidavit of , and confirm the contents thereof to be true and correct in so far as they relate to me.

[please refer to note 6]

_____________________________________

DEPONENT

THUS SIGNED AND SWORN TO BEFORE ME AT…………………………...........

THIS .…….......DAY OF ....................…………........... 2015,

THE DEPONENT HAVING ACKNOWLEDGED THAT HE/SHE* KNOWS AND UNDERSTANDS THE CONTENTS OF THIS AFFIDAVIT, THAT HE/SHE* HAS NO OBJECTION TO TAKING THE PRESCRIBED OATH AND THAT HE/SHE* CONSIDERS THE PRESCRIBED OATH/SOLEMN AFFIRMATION* TO BE BINDING ON HIS/HER* CONSCIENCE, AS REQUIRED BY GOVERNMENT GAZETTE NOS. R1258 OF 21 JULY 1972 AND R1648 OF 19 AUGUST 1977.

[*delete whichever is not applicable]

___________________________________

COMMISSIONER OF OATHS

_____________________________________________

FULL NAME AND SURNAME OF COMMISSIONER

(IN BLOCK LETTERS)

_____________________________________________________________________

BUSINESS ADDRESS OF COMMISSIONER

_________________________

DESIGNATION

_________________________

AREA

 

SAVC Login

Links to African Council websites

Veterinary Statutory Bodies in Africa
http://www.rr-africa.oie.int/en/RC/en_vsbs.html

Veterinary Council of Namibia
http://www.van.org.na/section.php?secid=10

Veterinary Council of Zimbabwe (department of livestock and veterinary services)
http://www.dlvs.gov.zw/

Kenya Veterinary Board
http://kenyavetboard.org/

Veterinary Council of Tanzania
http://www.mifugouvuvi.go.tz/vertinary-council-of-tanzania/

Botswana Veterinary Association
http://www.bva.org.bw/bva_content.php?id=2

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