The government has just adopted Bill No. 61.24 approving Decree-Law 2.24.728 of September 27, 2024 supplementing Law No. 17.04 relating to the Medicines and Pharmacy Code.
These new provisions aim to strengthen transparency and efficiency in the pharmaceutical sector, while simplifying administrative procedures.
Supervision of drug advertising
Advertisements intended for the general public and health professionals will now have to obtain prior authorization from theMoroccan Agency for Medicines and Health Products. Strict control will be exercised over the content of advertisements to guarantee clear and truthful information.
The medicine concerned by the advertisement must not be subject to suspension or withdrawal of the marketing authorization.
Any pharmaceutical company wishing to obtain advertising authorization must compile a file including:
1-A request signed and sealed by the pharmacist responsible for the pharmaceutical company, mentioning:
- The name, form and dose of the medication;
- The name or designation of the pharmaceutical company, as well as its address or head office;
- The advertising methods chosen;
- The references of the marketing authorization of the medicine.
2-An updated summary of the characteristics of the medication, signed by the responsible pharmacist.
3-The advertising project on an electronic medium.
4-A copy of the payment receipt made to the Agency. Please note that the price is set by decision of the board of directors of the said Agency.
5-The scientific references of the advertising, if applicable.
-“The authorization application file is submitted to the Agency, which decides within a maximum period of sixty (60) days from the date of complete submission of the file. Any refusal decision must be reasoned and notified to the “pharmaceutical company concerned”, specifies the decree.
The advertising authorization is valid for a period of one year, renewable within the limit of the validity period of the marketing authorization.
Each advertisement must be designed in such a way as to make the advertising nature of the message addressed to the general public clear and to clearly identify the product as a medicine. This message must include, in particular, the following information:
- The name of the medicine and its usual or scientific name;
- The serial number of the advertising authorization mentioned in the second paragraph of Article 42 of the aforementioned Law No. 17.04;
- Information necessary for correct use of the medication;
- An invitation to read the instructions on the leaflet or on the outer packaging of the medicine, as appropriate;
- The name or designation of the industrial pharmaceutical company concerned.
In addition, any advertising of a medication intended for the general public must include the following warning: “Consult a doctor or pharmacist if symptoms persist. »
Furthermore, the Agency may suspend or withdraw the advertising authorization, as appropriate, if the marketing authorization for the medicinal product concerned is suspended or withdrawn or if it finds that the pharmaceutical company concerned has infringed the provisions regulations in force. Any decision to suspend or withdraw the advertising authorization must be justified and notified to the company concerned.
Note that Law No. 17.04 stipulates that any advertising of a medicine to health professionals must be the subject of an application file filed with the Moroccan Agency for Medicines and Health Products. The pharmaceutical company may launch advertising to healthcare professionals after a period of fifteen (15) days from the complete submission of the file to the Agency. However, if the latter identifies observations after examining the file, it communicates them to the company within the aforementioned deadline, giving reasons for its remarks. In this case, the company must respond to the observations raised before the end of the deadline.
Certification of conformity
A certification system has been established to verify compliance with good manufacturing practices for medicines. Pharmaceutical companies will need to obtain this certification for each site or production line.
To obtain a free sale certificate, the company concerned must compile a file including the following documents:
- A request, established according to a model established by decision of the government authority responsible for health, signed and sealed by the pharmacist responsible for the industrial pharmaceutical company;
- A copy of the marketing authorization for the medicine concerned;
- A sworn declaration in which the responsible pharmacist certifies that no modification has been made to the elements of the marketing authorization for the medicine concerned, in accordance with the provisions of Article 13 of Law No. 17.04 aforementioned;
- A note relating to the state of reserve stocks of the medicine intended for export;
- A copy of the payment receipt made to the agency
- Any additional document that the industrial pharmaceutical company deems useful for the study of its request.
The free sale certificate application file is submitted to the Agency against receipt. The latter shall decide within a maximum period of sixty (60) days from the date of submission of the complete file. Any decision to refuse to issue the certificate of free sale must be justified and notified to the industrial pharmaceutical company concerned in accordance with the legislation in force. Please note that this certificate is issued for a period of two years, within the limit of the validity period of the marketing authorization.
