Marketing Authorisation Holders

Article 20 requires marketing authorisation holders to ensure that all relevant information about suspected adverse reactions to centrally authorised products is brought to the attention of the Agency.

Article 22 requires holders of centralised marketing authorisations to ensure that all suspected serious adverse reactions occurring within the EU to one of their products, that are brought to their attention by a health care professional, are recorded and reported within 15 days to the Member States where the incidents have taken place. Marketing authorisation holders must also ensure that all suspected serious unexpected adverse reactions occurring in the territory of a third country are reported immediately to the Agency in addition to all the Member States, within 15 days. Commission Regulation (EC) No. 540/95 sets out the arrangements for reporting suspected unexpected adverse reactions to centrally authorised medicinal products for human (or veterinary) use which are not serious, whether occurring in the EU or a third country; see Appendix 3.

As with holders of marketing authorisations granted under national or mutual recognition procedures, marketing authorisation holders for centrally authorised products are required to maintain detailed records of all suspected adverse reactions occurring within or outside the EU reported to them by health care professionals.

Subject to the specific terms of a marketing authorisation, periodic safety update reports (accompanied by a scientific evaluation) must be submitted to both the Agency and Member States:

* immediately upon request; or

* at least every six months during the two years after a medicinal product has been granted a marketing authorisation; or

* once a year between the second and fifth years following the grant of a marketing authorisation.

At the end of the five-year period following authorisation, periodic safety update reports must be submitted every five years together with each marketing authorisation renewal application.

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