MA – Market Authorization of Medicines in Pharmaceuticals: a complete guide

3. The procedure for obtaining Marketing Authorization (MA)

a. The pharmaceutical MA file

To obtain Marketing Authorization (MA), the pharmaceutical company must compile and submit a Marketing Authorization Application (MAA) dossier to the relevant authorities containing:

• An efficacy section: including all the results from clinical studies conducted on humans, demonstrating the efficacy and exact conditions of the drug’s use.
• A quality section: detailing quality data of raw materials, manufacturing processes, and quality controls.
• A safety section: with information on the product, its composition, therapeutic indications, pharmacology, toxicology, pharmacokinetics data, and side effects.

b. The stages in the marketing authorization procedure

Drugs intended to be marketed in the member countries of the European Union are subject to a “centralized” marketing authorization (MA) procedure with the EMA. The centralized MA is the most commonly used procedure compared to the more limited application of national MA procedures.

1. The submission of the MA dossier: the pharmaceutical company that wishes to market a drug submits the MA dossier to the regulatory authorities. This dossier contains all information on the drug’s efficacy, quality, and safety.
2. The evaluation of the MA dossier: the regulatory authorities evaluate the dossier to verify that the product meets all safety, efficacy, and quality criteria.
3. The approval of the MA dossier: if the product meets all the requirements, the MA is granted, authorizing the commercialization of the product.

c. Temporary Authorization for Use (ATU)

The Temporary Authorization for Use is an exceptional measure applied in certain circumstances. It is a French compassionate program allowing the use of drugs before their marketing authorization (MA).

It allows the availability of drugs before their commercialization, to meet a public health need for a limited period.

The drug is exclusively provided to patients with serious or rare diseases who have no other treatment options available, by specialist doctors in a hospital setting.

4. The Marketing Authorization (MA) at the heart of the production of double-tipped ampoules by SFAM

At SFAM, our double-tipped glass oral ampoules are designed to comply with pharmaceutical regulations, and ensure all quality and safety standards required during the marketing authorization applications for medications.

Our double-tipped ampoules are manufactured according to high-quality standards, including ISO 9001 and ISO 15378 standards.

Last but not least, during their production, rigorous quality controls ensure their safety and compliance.