- About SAM
- EU Council presidency
- Human medicines
- Marketing authorisation
- Drug information
- Clinical trials
- European Pharmacopoeia
- Pharmacovigilance
- Classification of medicinal products
- Statistics
- Manufacture, distribution, pharmacy
- Travelling with medicinal products
- The import and export of goods that require a special authorization
- Sending of medicinal products
- Advertising
- Marketing authorisation
- Veterinary medicines
- Department of Biologicals
- Blood handling
- Procurement and handling of cells, tissues and organs
- Biovigilance
- Application of cells, tissues and organs licence
- List of licensed procurers and handlers of cells, tissues and organs (tissue establishments)
- Legislation for procurement and handling cells, tissues and organs
- Special authorisation for import and export and notification of import and export of cells, tissues and organs
- Advanced therapies medicinal products
- The import and export of goods that require a special authorisation
- Legislation
- Supervision
- Laboratory
Changes in reporting adverse drug reactions to Eudravigilance
08.12.2017
Responsibilities of Marketing Authorisation Holders
MAHs need to submit electronically to EVPM information on all serious suspected adverse reactions that occur in the Union and in third countries within 15 days following the day on which the MAH concerned gained knowledge of the event.
MAHs need to submit electronically to EVPM information on all non-serious suspected adverse reactions that occur in the Union, within 90 days following the day on which the MAH concerned gained knowledge of the event.
There is no need to additionally notify the State Agency of Medicine.
There will be no changes to the reporting of SUSARs during clinical trials.
State Agency of Medicines
