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BalanceNo medicinal product may be placed on the market without registration or a Marketing Authorization (MA) has been issued.

The application for registration (also called Marketing Authorization Application - MAA) must demonstrate that the medicinal product meets the safety, efficiency and quality requirements.

The creation of registration dossiers (CTDs = Common Technical Documents) is done in accordance with the European Directives (http://europa.eu.int/enterprise/pharmaceuticals/eudralex/index.htm) and/or international legislation.

The documents shall be presented as five modules:

  • Module 1: administrative information (country-specific)
  • Module 2: expert’s report
  • Module 3: qualityQA
  • Module 4: non-clinical reports
  • Module 5: clinical study reports

The same applies to clinical trials (CTA: Clinical Trial Application). A dossier (IMPD) comprising these same modules is to be submitted for each investigational drug. (IMP: Investigation Medicinal Product).

A number of registration procedures have been established that may lead to the granting of a Registration or a Marketing Authorization:

  • the national procedure,
  • the mutual-recognition or decentralized procedure,
  • the centralized procedure (involving EMA).

In addition, there are several types of files, each with their own characteristics: complete dossier, bibliographic record, dossiers for biotech products, for veterinary products, for "orphan medicinal products", for pediatric, homeopathic and herbal products, etc.

The "Regulatory Affairs" department of a pharmaceutical company is tasked with the drafting of MAA dossiers and notices, the follow-up with the authorities during the evaluation phase of the file, the monitoring of national and European legislation, the preparation and submission of "variations" (changes) after obtaining the MA and the application for registration renewal.