15.07.2024 - notice within the graduated plan procedure (“Stufenplanverfahren”)

By decision of 17 June 2024, the Federal Institute for Drugs and Medical Devices (BfArM) implements the decision of the European Commission of 24 May 2024 for the German marketing authorisations. This concludes the European risk assessment procedure in accordance with Article 31 of Directive 2001/83/EC for medicinal products for which studies were conducted by Synapse Labs Pvt. Ltd-Private Limited Company, a contract research organisation (CRO) based in Kharadi, India.

20.06.2024 - European Commission final decision

With the publication of the European Commission's decision, the risk assessment procedure according to Article 31 of Directive 2001/83/EC on medicinal products for which studies were conducted by Synapse Labs Pvt. Ltd., a contract research organisation (CRO) based in Kharadi, India, has been completed. Numerous generic marketing authorisations for which authorisation-relevant studies were carried out by this contract research organisation are now suspended.

The commission decision and its annexes can be found here:

Union register of medicinal products

25.03.2024 - CHMP opinion (re-examination)

On 21 March 2024, EMA’s human medicines committee (CHMP) confirmed its recommendation to suspend or not grant the marketing authorisations of a number of generic medicines tested by Synapse Labs Pvt. Ltd., a contract research organisation (CRO) located in Kharadi, India. This confirmation concludes the re examination requested by the applicants and marketing authorisation holders for some of the medicines concerned.

15.12.2023 - CHMP opinion

EMA’s human medicines committee (CHMP) has recommended the suspension of the marketing authorisations of a number of generic medicines tested by Synapse Labs Pvt. Ltd., a contract research organisation (CRO) located in Kharadi, India.

21.07.2023 Start of procedure

The European Medicines Agency (EMA) has started a review of medicines for which studies have been conducted by Synapse Labs Pvt. Ltd., located in Kharadi, India.

Further information

For details on the procedure please click on the following link to the homepage of the European Medicines Agency (EMA):