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DEPARTMENT OF AGRICULTURE, FORESTRY AND FISHERIES
NO. 302   08 MARCH 2019
302 Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act (36/1947): Proposed Regulations Regarding Stock Remedies  42286  
DEPARTMENT OF AGRICULTURE, FORESTRY AND FISHERIES 
 
FERTILIZERS, FARM FEEDS, AGRICULTURAL REMEDIES AND STOCK REMEDIES ACT, 1947  
(ACT No. 36 OF 1947) 
 
PROPOSED REGULATIONS REGARDING STOCK REMEDIES 
 
 
I, Senzeni Zokwana, Minister for Agriculture, Forestry  and Fisheries, acting  under Section 23 of the 
Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act No. 36 of 194 7), hereby -  
 
(a) make known that I intend to make regulation s on Stock Remedies  in the schedule to come into 
force on 1 April 2019 ; and  
 
(b) invite interested persons to submit any objections to or representations concernin g the proposed 
regulations in writing to the Registrar: Fertilizer s, Farm Feeds, Agricultural Remedies and Stock 
Remedies Act, 1947 (Act No. 36 of 1947) , Private bag X 343, Pretoria, 0001,  or via email to 
MalutaM@daff.gov.za; within eight weeks from date of publication hereof. 
 
 
 
 
S Zokwana 
Minister of Agriculture, Forestry  and Fisheries. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
INDEX  
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Page 
1. Definitions …………………………………………………………………………………………  3 
 
 PART 1 - REGISTRATION  
2. Application for registration ……………………………………………………………………….  4 
3. Period of valid ity and renewal of registration 4 
4. Application for transfer of registration................................................................................ 5 
5. Return of certificate of registration ……………………………………………………………..  5 
   
 PART II - LABELLING, CONTAINERS AND ADVERTISEMENT   
6. Containers of stock remedy ……………………………………………………………………  6 
7. Labelling of containers ……………………………………………………………………………  6 
8. Approval of advertisements …………………………… ......................................................... 7 
9. 
 
 
10 
11. Publication  or distribution of false or misleading advertisements…………………………...  
 
                           PART III -PRODUCT GROUP AND EXTRA -LABEL USE 
Product groups 
Extra -label use of stock remedy    .....................................................................................  7 
 
 
8 
8 
   
 PART IV - MANUFACTURING ESTABLISHMENTS 
  
12. Manufacturing at establishments ………………………………………………………………..  9 
13. Suitab ility of  establishments …………………………………………………………………….  9 
14. Records at establishments ………………………………………………………………………  10 
   
 PART V - SAMPLING AND PERMISSIBLE DEVIATIONS  
15. Sampling of Stock Remedy ……………………………………………………………………  10 
16. Permissible deviations in active ingredients content ……………………………………….  11 
   
 PART VI - HANDLING, STORAGE AND DISPOSAL OF STOCK REMEDY 
  
17. Handling of Group 1 stock remedy …………………………………………………………….  11 
18. Disposal of Stock R emedy  …………………………………………… ..................................... 11 
   
 PART VII – IMPORTS 
  
19. Importation of Stock Remedy  ………………………………………………………….……… .. 11 
20. Ports of entry through which imports may be made ………………………………………….  12 
   
 PART VIII - APPEALS   
21. Submission of appeal …………………………………………………………………………..  12 
22. Address for submission of appeal ……………………………………………………………..  12 
   
 PART IX – GENERAL   
23. Offences and penalties ……………………………………………………………………..……  13 
24. Payment of fees …………………………………………………………………………………..  13 
25. Address for submission of documents …………………………………………………………  13 
26. Amendment and repeal of certain regulations …………………………………………………  13 
   
  
 
 
 
  
   
   
   
   
   
 
SCHEDULE 
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1. Definitions 
 
In these regulations,  
 
"applicant"   means the person in whose name an application for the registration of a stock remedy has 
been filed; 
 
“fee”  means the prescribed  fees as published annually by Minister in a Government Gazette; 
 
‘’complaint ” means any written, electronic, or oral communication that alleges deficiencies related  to the 
identity, quality, durability, reliability,  safety, effectiveness, or performance of a stock remedy  after it is 
released for distribution 
 
“establishment ” means the premises where stock remedy is manufactured, controlled, packed, marked 
or labelled for the purpose of sale 
 
“extra -label use”  means the use of a stock remedy by a veterinarian  without following the label 
recommendations  
 
"invoice"  means a detailed list of goods sold or services rendered with an account of all costs listed pe r 
item. 
 
"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 a person or entity that manufacture a  stock remedy; 
 
“minister”  means the Minister of Department of Agriculture, Forestry and Fisheries; 
 
"registered name"  means the name of stock remedy approved by the R egistrar under which a stock  
remedy is registered 
 
“registration holder”  means the person to whom a certificate of registration in respect of a particular 
stock remedy has been issued; 
 
“republic”  means Republic of South Africa 
 
“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. 
 
“the Act”  means the Fertilizer, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 
(Act No. 36 of 1947) 
 
"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; 
 
 
 
 
 
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PART I  
 
REGISTRATION 
 
2. Application for registration 
 
(1) An application in terms of section 3(1) of the Act, for the registration  or amendments  of a 
stock remedy  must be submitted to the Registrar in duplicate  on form  obtainable from the Registrar ’s office .  
 
(2) An application may 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 applic ation shall be accompanied by:  
 
(a) the applicable fee;  
(b) two copies of application form signed by  an approved person; 
(c) two copies of a typed label, in English. If any other language is used such  label 
shall be submitted in  duplicate with an affidavit from the sworn translator declaring 
the label to be a true translation of the English label; 
(d) all scientific documentation necessary for demonstrating the safety, quality and 
efficacy of the product; 
(e) in the case of:  
(i) clinical trial (s), app roval  by an Animal Ethics Committee, which conform s 
to SANS 10386:  2008  
(ii) manufacture and quality assurance , a copy of a Good Manufacturing 
Practice (GMP)  certificate or other recognised accreditation certificate  
(iii) analytical and laboratory data, proof or confirmation of compliance with 
Good Laboratory Practice  (GLP) or a quality assurance certificate issued 
by a recognised authority. 
(f) a detailed and critical expert report that has been drafted and signed by a person 
with the requisite technical or professional qualifications and that has a brief 
curriculum vitae of the person signing the report attached to it; 
(g) proof of the existence of a manufacturing site, which may include a Site Master 
File; 
(h)  the Registrar may request additional data or sample which  may assist in evaluation 
of a stock remedy  
 
(4) The information referred to in sub-regulation (3) shall be submitted in English 
 
(5) In a case o f a stock remedy  registered in terms of the Act is to be registered in favour of 
another person or company, such an application must be accompanied by a  declaration from the 
registration holder that such registration can be made in favour another person or company. 
 
Period of v alidity and r enewal of registration  
 
3. (1) a registration issued in terms of section 3(3) of the Act will be val id for a period of three   
years after registration. 
 
(2) A registration referred in sub -regulation (1) which has expired may be renewed in terms of 
section 3(4) (a) of the Act if it has been submitted to the Registrar’s office o n a prescribed 
form obtainable from the Registrar ’s office . 
 
 (3) An application  for the renewal of a registration  shall -- 
 
(a) be made by the registration holder  on the form  obtainable from the Registrar’s 
 office ; 
(b) be submitted to the Registrar  at least three months before the expiry date of the 
registration concerned; and  
(c) be accompanied by the applicable renewal fee 
 
(4) An application made in terms of sub-regulation 3 (1) which:  
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(a) is received by the Registrar after the expiry date, but n ot more than 30 days after 
such expiry date, shall be considered only if it is accompanied by the late penalty  
fee;  
(a) which is received by the Registrar after the days of grace referred to in sub-
regulation 3(4)(a) will not be considered  for renewal.  An application for 
reinstatement must be made . 
 
 (5) Any person who applies for the renewal of a registration in terms of this regulation shall in 
an affidavit confirm that the details furnished with such application in respect of the stoc k 
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 regis tered 
or approved in relation to that stock remedy or label. 
 
(6) A renewal of a registration for a  registered stock remedy in terms of  section 3 (4) (a) of the 
Act shall be  granted on condition that during the period of 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 connecti on 
with the sale of the stock remedy concerned, shall not be al tered without the prior written 
approval of the Registrar;  
(c)  the details of the manufacturer of the active ingredient/s and the formulated product 
 shall not differ from the approved details; and 
(d) all conditions determined by the Registrar are met. 
 
Application for transfer of a registration 
 
4. (1) An application for transfer of a registration shall be made by, a person who is r esident 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) two copies of the application form o btainable from the Registrar’s office;  
(b) be accompanied by the application fee; 
(c) the reasons for the transfer; 
(d) the current registration certificate of the stock remedy to be    transferred; 
(e) a written consent from the current registration holder of the stock remedy 
 authorising the transfer of the registration;  
(f) a letter of acceptance from the new applicant 
(g) a declaration from the new applicant confirming that the particulars furnished in the  
application and the approved  label, remain identical to those o n the registered 
stock remedy with the exception of the details of the registration holder.   
 
Return of registration certificate 
 
5.  A registration certificate that is  returned in terms of s ection 4A (3) of the Act, should reach 
 the Registrar within 14 days of the day on which – 
 
(a) the person to whom the particular registration certificate has been issued is informed in 
 writing in terms of section 5 of the Act of the reason for cancellation of such registration; 
(b) the registration of the stock remedy has lapsed in terms of section 4A (2) of the Act; 
(c) in case of transfer or amendments a new certificate is issued  upon approval of such 
 application; and 
(d) if the original certificate of registration is lost, an affidavit must be submitted to t he 
 Registrar’s office confirming that the certificate of registration is lost.  
 
 
 
 
PART II  
 
LABELLING, CONTAINERS AND ADVERTISEMENT S 
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Containers of stock remedy  
 
6. (1) Subject to the provisions of any other law relating to containers, a contai ner in which a  
quantity of a stock remedy is packed for sale, shall at the time of packing: 
 
(a) be approved by the Registrar  
(b) be in good condition, without damage  and be clean  
(c) be closed or sealed in the manner approved by the Registrar  
 
(2) The container shall - 
 
(a) once t he contents thereof have  been used , not be permitted for use for any other 
purpose; and 
(b) in the case of a liquid stock remedy, prevent spillage when pouring out the contents 
thereof. 
 
(3)  S ubject to the provisions of the Legal Metrology Act, 2014 (Act No. 9 of 2014 ), in containers 
that have been sealed or closed in a manner allowed by  the natur e of the stock remedy  
and containers shall be labelled or marked in terms of the provisions of Regulation 7. 
 
(4) Notwithstanding the provisions of  sub-regulation 6 (1), a  stock remedy  may be sold in a 
manner  other than in the approve containers if: 
 
(a) the container used is the same as the approved container in which the product is 
sold; and 
(b) the requirements of these regulations are met. 
 
Labelling of containers  
7.  (1)  No person may sell any stock remedy in a container 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  and those approved by the Registrar  or in 
terms of a provision of any other  law. 
 
(3) T he following as per the guideline must be provided on the immediate  packaging ; outer 
container; package insert, in legible characters —  
(a)  t he words “’For (external) animal use only”  
(b)  the class of the remedy  
(c)  where applica ble, the word s “’Restricted use in terms of the Veterinary and Para-     
Veterinary Professions Act, 1982 (Act No . 19 of 1982) 
 where applicable, the words “’for a notifiable or controlled diseases in terms of 
the Animal Diseases and Parasites Act, 1984 (Act No.  35 of 1984) 
(d)  name of remedy (Trade name) 
(e)  r egistration n umber 
(f)  c laims for Remedy , the target species;  
(g)  toxicity Indications 
(h)  storage Instructions 
(i)  manufacturing date 
(j)              expiry date  
(k)  composition , Contents, i.e. volume or quantity of product pack 
(l)  name and Address of Registration Holder (Ap plicant)  
(m)  warning(s) 
(n)  precautions 
(o)  directions for u se 
(p)  lot number, expiry date and date of manufacture  
(q)  for food-producing species, the withdrawal period for each species or animal 
product concerned  
      (r)                information on disposal of containers and expired stock remedy  
 (4) Approval of labelling does not absolve the registration holder from the o bligations of 
complying with the South African National Standards or any other relevant legislation.  
 
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Approval of advertisements 
 
8. (1) No advertisement shall be published , screened or broadcast without prior approval of the  
Registrar. 
 
(2) Approval of advertisements does not absolve any person or company from the obligations 
of complying with the prescriptions of t he Advertising Standards Authority of South Africa 
or any other relevant legislation. 
 
Publication or distribution of false or misleading advertisements 
 
9. (1) No person shall publish or distribute any false or misleading advertisement relating to a  
stock remedy.  
 
(2) Stock remed ies which fall within  Group A and  B may  not be advertised to the public  
 
(3) Specific scientific claims in an envisaged advertisement must be submitted for approval 
by the Registrar.  
 
(4) The advertisement shall have the following details: 
 
(a) An advertisement shall when publ ished in a newspaper, magazine or media  furnish a 
minimum of the following; 
(i) the trade mark, if any, and the trade name of the stock remedy; 
(ii) where it is applicable furnish the hazard statement; 
(iii) indicate the name  and amounts  of the active ingredient which it contains; 
(iv contain the registration number of the stock remedy in question together with a 
reference to the Act as “Reg. No. ………. Act 36/1947”; and  
(v) the name, contact details and address of the registration holder. 
 
(2) An advertisement shall, when screened or broadcast, have those details  referred to in sub -
regulation 4 (a)(1) (i) and (iv ). 
 
(3) Any reference in an advertisement to -- 
 
(a) an active ingredient; and 
(b) the instructions for use, claims, application or administration 
 
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 statement made in advertisements  must be  supported with scientific data  which must 
be submitted to the Registrar. 
  
(5) All advertisements must comply with the prescript s of the Advertising Standards Authority 
of South Africa (ASA). 
 
 
 
 
 
 
 
 
 
 
 
 
 
PART III  
PRODUCT CLASS AND EXTRA-LABEL USE 
 
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Product classes 
 
10 (1) The following are the classes of stock remedy : 
 
(a) Group A – Prescription stock remedy; for access and use only by Veterinarian s registered 
in terms of the Veterinary and Para-Veterinary professions Act, 1982 (Act No . 19 of 1982 ). 
Not to be advertised to the  general public  
 
(b) Group B – stock remedy  for access or  use by Veterinarian or Para - Veterinar y 
Professionals  registered in terms of Veterinary and Para-Veterinary Professions Act, 1982  
(Act No. 19 of 1982 ; Not to be advertised to the general public 
 
(c) G roup C – stock remedy  available o ver the counter for access by  the general  public.  May 
be advertised to the general public.          
 
(d) The Registrar shall publish a list of stock remed ies referred to in sub -regulation s (10)(1)(a), 
(b) and (c) in a Government Gazette.   
 
Extra-label use of stock remedies 
 
11.(1) The extra -label use of any stock remedy  shall be carried out under the following conditions:  
 
(a) only a veterinarians registered in terms of the Veterinary and Para -Veterinary 
Professions Act, 1982 (Act No. 19 of 1982) may use a stock remedy in a manner other  
than that indicated on the label (extra- label);  
  
(b) only stock remedy a registered in terms of the Act may be used extra- label  
 
(c)  a stock remedy may only be used extra- label  if there is no other stock remedy registered 
   for that purpose in that species of animals 
 
(d) a stock remedy used in terms of regulation( 1 1) (extra- label)  is not permitted for inclusion 
in animal feeds or for growth promot ion purpose s for use in animals producing food for 
human consumption without prior approval of the Registrar;  
 
(e) a veterinarian using a stock remedy  extra- label  in food-producing animal s shall specify an 
appropriate withdrawal period;  
 
(f) the withdrawal period must ensure that, if there is a maximum residue limit specified for the 
active substance, the residue does not exceed that limit or pose a risk to public health. 
 
(2) The veterinarian shall keep detailed records of the animals treated, the diagnosis or 
clinical assessment, the products administered, the dosage administered, the duration of 
treatment and the withdrawal period applied, for a minimum period of 5 years 
 
(3) The Registrar shall publish a list of stock remed ies prohibited for extra label use in the 
Government Gazette 
 
 
 
 
 
 
 
 
 
 
 
PART IV 
 
MANUFACTURING ESTABLISHMENTS 
 
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Manufacturing at establishment 
 
12 (1)     The practices in respect of the operation at an establishment and which relates to th e 
manufacture of a stock remedy for the purpose of sale, shall be such that the composition and 
efficacy of the stock remedy in question complies with the details register ed in respect thereof, and 
ensure 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 therefrom, shall be handled and stored at the premises of an establishment in 
such manner that -- 
(a)      raw materials used for the manufacture of a stock remedy, and the stock remedy 
                       manufactured therefrom shall be handled and stored in such a manner that they are 
                       protected against damage, contamination and deterioration, and a re stored under 
                       controlled access by authorised person 
 
(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 i s 
registered or by a competent body which is recognised for this purpose. 
 
(4) An employee at an establishmen t who is responsible for the manufacture, control, packing, 
marking and / or labelling of a stock remedy shall – 
 
(a) 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; and 
  
(b) on request provide the Registrar with proof of all control tests carried out on the stock 
remedy product or the constituents and intermediate products of the manufacturing 
process in accordance with the data submitted in support of the application for the 
marketing authorisation 
 
(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 in such a manner that if  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. 
 
Suitability of establishment 
 
13. (1) An establishment where a stock remedy is manufactured  in term of section 3 (4)(a), for the  
purpose of sale, shall: 
 
(a) have  been  inspected and  issued with a Good Manufacturing Practice certificate; or  
(b) have in place a system of Quality Assurance  
 
(2) Such an establishment shall have in place f acilities and equipment that ensure that a 
stock remedy shall be manufactured, packed and labelled in the manner determined in 
the dossier/submission and that the composition and efficacy of the stock remedy 
concerned complies with the requirements registe red in respect thereof, and that it 
possesses the chemical, physical and other properties thus registered. 
 
 
 
 
Records at establishments 
 
14. (1) a person managing the establishment shall, in respect of each batch of the different s tock   
remedy manufactur ed, controlled, packed or labelled on the premises , keep 
comprehensive records of: 
 
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(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, the date   
        and the quantity thereof which is sold to each such person; 
 
(d) complaints which were received in connection with the composition , safety  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 14(1) as well as the 
formula for formulating a batch of a stock remedy shall be preserved at such 
establishment for at least five years after the date on which the batch was manufa ctured. 
In the case of raw materials after the date of first receipt , provided that if a complaint 
referred to in sub -regulation 14(1) (d) was received, the records in respect of the batch in 
question shall not be destroyed within five years from the date of such complaint. Records 
shall always be available at an establishment for inspection by the Registrar or authorised  
persons .   
 
 
PART V  
 
SAMPLING AND PERMISSIBLE DEVIATIONS    
 
Sampling of stock remedy 
 
15. (1) A stock remedy that is sold in containers shall be sampled by selecting at di fferent  
places from the particular stock remedy the number of containers required to obtain a 
significant quantity for a sample of such a stock remedy , subject to the following conditions:  
 
(a) Such containers shall be similarly labelled,  and the stock remedy therein shall originate 
from the same batch. 
 
(b) Where a sample is composed of the contents of more than one container, such a 
sample shall be thoroughly mixed before being divided ;  
 
 
(c) Notwithstanding the provisions sub-regulation 15(1)(a), a t 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 in a n approved  container shall be sampled by taking small 
quantities at different places from the bulk stock of such stock remedy to obtain a sufficient 
quantity for a sample. Such a sample must be thoroughly mixed before being divided in 
terms of section 15(3) (c) of the Act.  Samples must be stored at the correct temperature, 
in accordance with registered storage conditions, until delivered to the analyst. 
 
 
(3)  The provisions of sub regulation  15 (2) shall mutatis mutandis  apply to the sampling of a 
stock remedy referred to in sub regulation 15(1) prior to the packing thereof in containers, 
and the sampling of an active ingredient used in the manufacture of a stock remed y. 
 
(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 rem edy, shall be 
procured. The containers thus procured shall be split up into three groups, each of which 
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 11 
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 a prescribed f orm (Annexure B) .  
 
(6) A certificate on which the result of a test, examination or analysis of a sample of a stoc k 
remedy shall be recorded as set out  in Annexure C. 
 
(7) That part of a sample of a stock remedy may-- 
 
(a) if a certificate referred to in sub regulation 15(5) indicate s 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 , such certificate shall be retained until 
the action arising from such certificate is concluded; or 
(b) otherwise be destroyed. 
 
 
Permissible deviations in active ingredient contents 
 
16. Notwithstanding 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 15(5) in relation to the analysis of a sample of such a stock remedy indic ates that the 
active ingredient concentration is within 10 % of the regis tered label claim, when the product is 
within its shelf life, and stored as instructed. 
 
 
PART VI  
 
HANDLING, STORAGE AND DISPOSAL OF STOCK REMEDY 
 
Handling of Group I Stock remedy 
 
17. Any person in control of an establishment selling, supplying or making available  Danger group I 
stock remedy 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 G roup 
I hazardous substances and keep such records as required. 
 
Disposal of stock remedy  
 
18.  (1) a stock remedy  shall only be disposed of by a waste treatment  facility authorised to destroy 
medicines or pharmaceutical waste in terms of the National  Environmental Management: Waste 
Act, 2008 (Act No. 59 of 2008). 
 
(2)  No stock remedy shall be disposed of into municipal sewerage systems or buried 
underground. 
 
 
 
 
 
 
 
PART VI I  
 
IMPORTS  
 
Importation of Stock remedy  
 
19. No person shall import a stock remedy into the Republic unless such remedy is regi stered: Provided 
that the Registrar may permit, in writing, the importations into the Republic of a specifi ed quantity 
of a stock remedy which is not registered for purposes of experimentation or for some purpose 
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 12 
other than the sale of such remedy. 
 
Harbours and places through which imports may be made 
 
20. No person shall import any stock remedy in terms of section 16 of the Act, into the Republic 
except through one of the following ports of entry: 
 
(a) Cape Town International Airport or harbour; 
(b) Port Elizabeth International Airport or harbour; 
(c) King Shak a International Airport or Durban harbour; and 
(d) O.R. Tambo International Airport. 
(e) any other entry point that the Registrar may permit on application or request 
 
 
PART VIII 
 
APPEALS  
 
Submission of appeals 
 
21. (1) An appeal in terms of section 6 of the Act shall be submitted to the Minister by deliv ering  
the documentation to t he Director -General within 60 days of the date on which the reasons 
for the decision  to appeal, 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 prescribed fee  
 
(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 pe rson concerned discloses interest in that decision or action. 
 
4) The amount referred to in sub -regulation 21(2)(e) shall be paid by cheque, postal order , 
electronic fund transfer  or money order made out in favour of the Director -General: 
Agriculture: pr ovided that if the appeal concerned is delivered by hand, such amount may 
be paid in cash. 
 
Address for submission of appeals 
 
22. An appeal referred to in sub-regulation 22 (1) shall: 
 
(1) when forwarded by post, be addressed to the Director -General, Department of Agriculture,  
Forestry and Fisheries, Private Bag X 250, Pretoria, 0001; and / or 
 
(2) when delivered by hand, be delivered to the Director -General, Department of A griculture, 
Agriculture Place , 20 Steve Biko  Street, Pretoria.  
 
 
 
PART IX 
 
GENE RAL  
 
Offences and penalties 
 
23. Any person who refuses or fails to comply with the provisions of these regulations sha ll be guilty of 
an offence and liable on conviction to a fine or imprisonment or to both a fine and imprisonment.  
 
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Payment of fees 
 
24. (1) the postage and delivery costs of any application or document submitted in terms of    
these regulations shall be paid by the sender.  
 
(2) fees payable in terms of these regulations must be paid by cheque, cash or electronic 
payment; 
 
(3) fees paid in  terms of these regulations, except in terms of Section 6 of the Act, are not 
refundable. 
 
Address for submission of documents 
 
25. Any application or document or anything else pertaining thereto, which is required i n 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 / or 
 
(2) when forwarded by rail or delivered by hand, be addressed or delivered to: 
The Registrar: Act No. 36 of 1947, Agriculture Building, 20 Steve Biko  Street, Pretoria.  
 
Amendment and repeal of certain regulations 
 
26. The following regulations are hereby repealed: 
 
(1) The Regulations relating to Stock remedy  published under Government Gazette Notice No. 
R857 of 28 May 1971 and;  
 
(2) The Regulations relating to Stock remedy  published under Government Notice No. R.  1449 
of 1 July 1983  and;  
 
(3) The Regulations relating to Stock remedy  published under Government Gazette Notice No. 
R956 of 29 September 2006  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ANNEXURE A 
agriculture,
forestry & fisheries
Department:
t Agriculture, Forestry and Fisheries
REPUBLIC OF SOUTH AFRICA
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CERTIFICATE IN RESPECT OF COLLECTION OF SAMPLES 
IN TERMS OF SECTION 15 OF ACT No. 36 OF 1947  
Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act No. 36 of 1947) 
(To be completed in duplicate) 
 
I here by certify that the accompanying sample of Stock Remedy identified by the above serial  
number, was taken by me on ____________________ .day of __________________________ 20______ 
At ______________________ i n the presence of ____________________________________________  
      *(Name of owner/person in charge of stocks/witness) 
from the stock of ___________________________________________________________________ ___ 
    (Name and address of seller/manufacturer )  
 
PARTICULARS OF STOCK  REMEDY FROM WHICH SAMPLE WAS TAKEN  
 
1. Name of registration holder  _______________________________________________________ 
2. Name of company ____________________________________________________________ 
3. Name of product†  ______________________________________________________________ 
4. Registration number†  _________________________________________________.Act 36/1947 
5. Manufacturer details  ____________________________________________________________ 
6. Composition of Stock Remedy†  
6.1 Chemical composition ________________________________________________________  
(List chemicals which appear on the label) 
__________________________________________________________________________ 
6.2 Physical properties  __________________________________________________________ 
__________________________________________________________________________ 
7. Conditions of container from which sample was taken __________________________________ 
8. Estimated quantity of Stock Remedy from which sample was taken: 
 8.1 Number of containers ________________________________________________________ 
8.2 Capacity of containers ________________________________________________________ 
9. Remarks _____________________________________________________________________ 
_____________________________________________________________________________ 
 
 
_____________________________________  ______________________________________ 
Signature of witness      Registrar 
_________________________________________________________________________________  
Notes 
* Delete whichever is applicable. 
† Shall be particulars as indicated on the affixed label of the containers from which the sample was 
taken or as it is marked on such containers, or if the Stock Remedy which is sampled, is not sold in 
containers, as it appears on the invoice which is supplied together with that Stock Remedy. 
‡ One copy shall accompany each of the three parts of the sample and the forth copy shall be kept by 
the officer who took the sample. 
 
 
 
 
 
 
 
ANNEXURE B 
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 15 
 
Analyst address 
…………….………..……………………………….  
 
 
 
CERTIFICATE OF RESULTS OF ANALYSES OR TEST OF A SAMPLE OF ASTOCK REMED Y BY 
ANALYST 
Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act No. 36 of 1947) 
(To be completed in duplicate) 
 
I (full name) _________________________________________________________________________ _ 
 
of _________________________________________________________________________________  
a duly appointed analyst in terms of section 14 of the Fertilizer, Farm Feeds, Agricultural Remedies and 
Stock remedy Act, 1947 (Act 36 of 1947) do hereby make oath and state: 
 
(a) that on _____________________ I received a sample of (a)______________________________ 
 
from _____________________ by _______________________(b) for analyses and/or test; 
 
(b) that the sample was labelled, sealed and marked(c) ____________________________________ 
 
_____________________________________________________________________________ 
 
(c) that I have analysed and/or tested the said sample and as a result of the analyses and/or test I 
found it to be constituted as follows:  
 
Pure active ingredient(d) 
          g/kg 
(a) _________________________________  __________ l__________ 
 
(b) _________________________________   ___________ l__________ 
 
(c) _________________________________  ___________ l__________ 
 
Other ingredients (if required) 
 
(a) _________________________________  ___________ l__________ 
 
(b) _________________________________  ___________ l__________ 
 
(c) _________________________________  ___________ l__________ 
 
Remarks _____________________________________________________________________ 
 
_____________________________________________________________________________ 
 
 
_____________________ 
Signature of analyst 
 
 
  
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ANNEXURE C 
 
 
DECLARATION TO BE MADE IN THE PRESENCE OF 
JUSTICE OF PEACE/COMMISSIONER OF OATH. 
 
 
TEL NO…………………………………  
 
DATE ………………………………….   INITIALS AND SURNAME … ……………………………..  
 
 
 ……………………………………………………………………………………………….  
SIGNATURE OF THE DEPONENT 
 
I certify that the deponent has acknowledged that he/she know and understands the contents of this 
declaration which was sworn to/affirmed before me and the dependents’ signature/thumb print/mark was 
placed thereon in my presence. 
 
 
 
  ………………………………………………………………………………………  
JUSTICE OF PEACE/ COMMISSIONER OF OATH 
 
 
Name and 
surname:…………………………………………………..................................................................................  
(BLOCK LETTERS) 
 
 
Designation (rank) :…………………………………... Ex Officio Republic of South Africa………………...  
 
Business 
address:……..……………………………………………………………………………………………………….  
(street address) 
 
Date:……………………………………………….  
 
Place.........…………………………………………  
 
________________________________________________________________________________ 
Notes 
 
(a) State name of Stock  Remedy as specified on label/insert name of person supplying the sample 
and state whether it was ”by hand”, ”by post” or by courier.  
(b) Insert distinguishing mark or number of sample. 
(c) State names of particular chemical constituents and physical properties. 
(d) State the name of the active ingredient