G/SPS/N/MAR/98  
26 April 2023 
(23-2953) Page: 1/3 
Committee on Sanitary and Phytosanitary Measures  Original:  French  
 
  
NOTIFICATION  
1. Notifying Member : MOROCCO  
If applicable, name of local government involved:  
2. Agency responsible : Office National de Sécurité Sanitaire des Produits Alimentaires , 
ONSSA (National Office for Food Safety)  
3. Products covered (provide tariff item number(s) as specified in national 
schedules deposited with the WTO ; ICS numbers should be provided in addition, 
where applicable) : Veterinary medicines and products for veterinary use  
4. Regions or countries likely to be affected, to the extent relevant or practicable:  
[X] All trading partners  
[ ] Specific regions or countries:  
5. Title of the notified document : Projet de décret No. 2-22-06 pris pour l'application de 
la loi No. 21-80 relative à l'exercice, à titre privé, de la médecine, de la chirurgie et de la 
pharmacie vétérinaires  (Draft Decree No. 2-22-06 implementing Law No. 21-80 on the 
private practice of veterinary medicine, surgery and pharmacy) Language(s) : French 
Number of pages : 25 
https://members.wto.org/crnattachments/2023/SPS/M AR/23_9266_00_f.pdf  
6. Description of content : The notified draft Decree, updating the Decree implementing 
Law No. 21-80, is part of the support measures for the veterinary pharmacy sector, which 
are intended to supply the animal husbandry sector with safe and effective veterinary 
products by upgrading pharmaceutical production units.  
The proposed draft text updates the regulatory provisions on the authorization/licensing 
of veterinary pharmaceutical establishments, marketing authorization for veterinar y 
medicines, post -marketing surveillance (inspection, quality control and 
pharmacovigilance) and the regulatory approval of quality standards for all activities 
(good manufacturing and distribution practices) in line with scientific and technical 
developme nts. 
This draft is intended to improve the regulatory framework for veterinary medicines 
significantly . It reworks the form and substance of the existing text . The principal 
amendments proposed aim to:  
1. Better position the chief pharmaceutical officers of veterinary pharmaceutical 
establishments in the performance, manufacture, importation and distribution of 
veterinary medicines;  
2. Update the legal framework for marketing authorizations for veterinary medicines and 
introduce a regulatory basis fo r the Joint Commission for Marketing Authorizations;  
3. Lay down the principle of setting technical standards for evaluating the operation of 
the establishments : good manufacturing and distribution practices;  
4. Provide details on market surveillance tools (insp ection, quality control and 
pharmacovigilance);  G/SPS/N/MAR/98  
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  5. Establish a legal framework for the administrative certifications required to export 
locally manufactured proprietary medicines (certificate of origin and free circulation 
(COLC), certificate of free circulat ion (CLC), certificate of a pharmaceutical product 
(CPP) and "CAT") and for the sanitary clearance of imported veterinary medicines.  
This draft Decree repeals Decree No. 2-82-541 of 1 5 March 1 983 implementing Law No.  
21-80 on the private practice of veteri nary medicine, surgery and pharmacy.  
7. Objective and rationale : [X] food safety, [X] animal health, [ ] plant protection, 
[ ] protect humans from animal/plant pest or disease, [ ] protect territory from 
other damage from pests.  
8. Is there a relevant international standard ? If so, identify the standard:  
[ ] Codex Alimentarius Commission (e.g. title or serial number of Codex 
standard or related text) : 
[X] World Organisation for Animal Health (OIE) (e.g. T errestrial or Aquatic 
Animal Health Code, chapter number) : Chapters 1.1.8. and 1.1.9. of the 
World Organisation for Animal Health (WOAH)  
[ ] International Plant Protection Convention (e.g. I SPM number) : 
[ ] None  
Does this proposed regulation conform to the relevant international stand ard? 
[X] Ye s [ ] No 
If no, describe, whenever possible, how and why it deviates from the 
international standard:  
9. Other relevant documents and language(s) in which these are available:  
10. Proposed date of adoption (dd/mm/yy) : To be determined  
Proposed date of publication (dd/mm/yy) : To be determined  
11. Proposed date of entry into force : [X] Six months from date of publication, 
and/or ( dd/mm/yy ): 
[ ] Trade facilitating measure  
12. Final date for comments : [X] Sixty days from the date of circulation of the 
notification and/or (dd/mm/yy) : 25 June 2 023 
Agency or authority designated to handle comments : [X] National Notification 
Authority, [X]  National Enquiry Point . Address, fax number and email address 
(if availa ble) of other body:  
Division de la Normalisation et des Questions SPS  (Standardization and SPS Matters 
Division)  
Direction de l'Evaluation des Risques et des Affaires Juridiques  (Directorate of Risk 
Assessment and Legal Affairs)  
Office National de Sécurité  Sanitaire des Produits Alimentaires  
Avenue Hadj Ahmed Cherkaoui  
Tel.: (+212 5) 37 67 65 11/13  
Mobile : (+212 6) 73 99 78 17  
Fax: (+212 5) 37 68 20 49  
Email: enquirypoint.spsmar@onssa.gov.ma  
Website: http://www.onssa.gov.ma  G/SPS/N/MAR/98  
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  13. Text(s) available from : [X] National Notification Authority, [X]  National Enquiry 
Point . Address, fax number and email address (if available) of other body:  
Division de la Normalisation et des Questions SPS  
Direction de l'Evaluation des Risques et des Affaires Juridiques  
Office National de Sécurité Sanitaire des Produit s Alimentaires  
Avenue Hadj Ahmed Cherkaoui  
Tel.: (+212 5) 37 67 65 11/13  
Mobile : (+212 6) 73 99 78 17  
Fax: (+212 5) 37 68 20 49  
Email: enquirypoint.spsmar@onssa.gov.ma  
Website: http://www.onssa.gov.ma