Marketing authorization

The marketing authorization or AMM is the agreement given to a Médicament to be marketed.

When a pharmaceutical laboratory wishes to on sale put an health product (drug, product of analysis, etc), it must present a dossier near the competent authority of the country concerned: national agency (such AFSSAPS in France, Head office of the drug (DGM) in Belgium), European (EMEA) or Food and Drugs Administration (FDA) with the the United States.

The Procedure of obtaining the AMM is particular in Europe. Indeed, according to the nature of the drug:

  • it will be " centralisée" by the European agency for the innovating products, such as the Anti-cancer;
  • it will be " nationale" , managed by each State in the cases untreated by the EMEA, such as the Generic S.

Nevertheless, if the drug is recorded by the same pharmaceutical laboratory in several countries, one has recourse to European procedures called " Procedure of recognition mutuelle" and " procedure décentralisée". In these two cases, the request file is examined at the same time by the whole of the agencies of the countries concerned.

Once the authorization obtained, it receives a number called differently according to the countries.

File of AMM

The drug " candidat" with obtaining a AMM is examined starting from a request file of authorization on the market. Today this file is written in a standardized format: the format CTD. This format is used in Europe, in the United States and Japan. The paus of Asia use a type of different file: ASEAN CTD.

A file for a new molecule comprises thousands of pages. It describes at the same time manufacture of substance activates (often starting from documents type Compliance certificate to the European pharmacopeia or Drug Master File which helps with the evaluation of the substance), the manufacture of the end product, the clinical studies and not-private clinics.

The file can be shortened when it is about a generic medicine, of a drug " of medical use well établi" ,… Certaines information is then not necessary (mainly clinical studies).

France

The agency of the drug (AFSSAPS) delivers with the Médicament an Identifying code of Speciality (CIS) composed of 8 digits, according to format X XXX XXX X.

for example, 6.336.833 2 is code CIS of Doliprane 500 Mg, compressed (Paracétamol)

The drug receives in more one Identifying code of the Presentation (CIP) which one finds on the box after the mention " Drug autorisé" and also on the Code bar. This code with 7 digits should pass to 13 digits starting from January 1st, 2009. Two codings should cohabit until 2012.

For example, Doliprane 500 Mg, tablet, is recorded out of box of 10,12,16,20 and 100 for the hospitals. Each presentation thus has its code CIP: 323.202-4 for the box of 10,321 816-5 for that of 12, etc

It is possible that all the presentations are not on sale.

Belgium

When the Médicament is accepted, it receives a number of license as follows composed:

F

  • the license identifies the pharmaceutical laboratory (for example 243)

  • the Code speciality: S if the drug is conditioned in Belgium, IS if it is imported
  • the number of the speciality is a simple sequence number (this number changes if the drug exists under various conditionings, for example into blister and bottle)
  • the letter F means form
  • the code form indicates of which dosage form:
    • F0 = powder, pellet, cigarette, spangle
    • F1 = pill, granule
    • F2 = pastille, shelf
    • F3 = Compressed, dragee
    • F4 = Seal, pulvules
    • F5 = capsule, Gélule
    • F6 = Suppository, ovule, candle, pencil
    • F7 = Ointment, Pomade, cream, Paste, Freezing, cerate, liniment
    • F8 = Syrup S, emulsion S
    • F9 = extracted, dyeing, gasoline
    • F10 = the, herb tea
    • noninjectable F11 = solution, aqueous solutions, balsams
    • injectable F12 = Solution
    • F13 = Eye lotion, ophthalmic pomade, ophthalmic lotion,
    • F14 = compressed for establishment
    • F15 = Plaster
    • F16 = produced sterile (bandage, compress, etc)
    • F17 = vaccine, serum, anatoxine, antigen
    • F18 = material sterile for blood Transfusion, Perfusion, injection or drainage, material of substitution or Prosthesis intern

By exemplen 779 IS 52 F3 indicate Nurofen smelt 200 Mg (Ibuprofène) recorded by Boots Healthcare (number 779), it is the 52e drug recorded by this laboratory, it is a tablet (from where the F3 code) and it is an imported drug (code IS, because manufactured in France).

Nullity of the AMM

The AMM must be renewed. It is about a procedure which takes place every five years in the majority of the countries.

The request for renewal is the occasion to give a progress report on the safety of the drug thanks to the data of pharmacovigilance: the compilation of the whole of the side effects declared since the beginning of the marketing of the drug is provided to the authorities. Within sight of the data of pharmacovigilance, the authorities of health can decide to withdraw the drug, of modifer the medical information (CCP, note) or nothing to make if the data do not show any effect engraves new.

In Europe, a new rule appeared in 2005 fact that the AMM is cancelled if the drug is not marketed during 3 years.

Withdrawal of the market

It may be that a drug is withdrawn from the market. Either directly by the laboratory, or at the request of the authorities of health when appears a serious problem. The AMM is then cancelled.

The authorities of health can refuse an economic withdrawal of market if the drug is the last in the treatment of a disease.

The reasons of the withdrawal of the market can be varied:

  • Health reasons: major Side effect undesirable, non-observance of the rules of manufacture…
  • Economic reasons: appearance of credits, appearance of more effective molecules, bankruptcy of the laboratory…

See too

  • List of drugs withdrawn from the market

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