In our past broadcasts, we have addressed the different types of medicines and about generic medicines and new molecules, and now it is time to deal with the Manufacturing License, one of the requirements to be the holder of the Sanitary Registry of a Medicine in Mexico.
In the first place, we have its legal basis, which is found in the Regulation of Health Supplies (Reglamento de Insumos para la Salud), which indicates in its article 168, “to be the holder of the sanitary registration of a medicine, it is required to have a Manufacturing License for a medicine factory or laboratory or biological products for human use. In the case of foreign manufacturers, it is required to have a license, certificate or document that proves that the company has permission to manufacture medicines, issued by the competent authority of the country of origin.
However, what is a Manufacturing License? To answer this question, we can rely on the General Health Law (Ley General de Salud), which in its article 368 indicates that the Manufacturing License is a Sanitary Authorization, which is an administrative act through which the competent Sanitary Authority allows a public or private person, carrying out activities related to human health.
With the above, we can realize that the Manufacturing License must be issued by a competent Sanitary Authority, therefore, if the applicant to be Holder of the Sanitary Registry is a National Manufacturer, the Manufacturing License must be requested to COFEPRIS, below we leave you the link where you can find the format, the instructions and the payment of associated rights for the request for the issuance of a Manufacturing License for the establishment of health supplies (Factory or laboratory of medicines or biological products, for human use).
https://www.gob.mx/cms/uploads/attachment/file/652304/COFEPRIS-05-001-B.pdf
On the other hand, if the applicant to be the Sanitary Registry Holder is a Foreign Manufacturer, the Manufacturing License must be issued by the competent Sanitary Authority of their country of origin.
Now, from the point of view of the application for the sanitary registration of a medicine, we must ask ourselves the following question: what are the characteristics that the Manufacturing License must have to be accepted by our Sanitary Authority when applying for the Sanitary Registry of a Medicine?
If it is of National Manufacture, it is required to present:
- Simple copy of the Manufacturing License and must:
- Indicate the company name and address of the applicant for the health registration (Holder)
- Endorse the Manufacturing Line of the requested medication
If it is of Foreign Manufacture, it is required to present:
- Original or certified copy of the license, certificate or document that proves that the company has permission to manufacture drugs and must:
- Indicate the Company name and address of the Holder.
- Be issued by the Sanitary Authority of the country of origin of the manufacturer who intends to be the holder of the Sanitary Registry
- Endorse the manufacturing line of the requested drug
- Be apostilled or legalized in the country of origin
- Have a translation into Spanish by an expert translator if the source language is different from English.
It is worth mentioning that, in the case of national manufacture, the Manufacturing License of the conditioner, distributor and/or maquiladora must also be presented, if they are involved in the Medication process and the Manufacturing License must endorse the line of the medication process in which they intervene.
Finally, if the medicine belongs to a controlled medicine, independently regardless of whether the Holder is national or foreign, we must also present the Manufacturing License of the Importer and/or Distributor and/or Legal Representative with scope in Warehouse for the Deposit and Distribution of Controlled Medicines or Biological Products, for Human Use.
If you are in the process of assembling of a Dossier to request a Sanitary Registration of a Medication or if you have any questions about Manufacturing Licenses, contact us at 55 6167 7092, we can help you with your project.
Give us your opinion on this topic addressed in our blog and share with us if you have any topic in Health Regulation that you want us to review in the next issue.
Comments powered by CComment