The Spanish Agency for Medicines and Healthcare Products (AEMPS) has informed about the possibility of requesting the temporary exemption from the obligation to carry out batch control analyzes in entities located in the European Union (EU) after leaving the United Kingdom , an informative note that describes the procedure, terms and conditions to be met for the request and granting of said temporary exemption.
Among the operations that the holders of authorization of medicines must change to an EU country before leaving the United Kingdom, are those of the manufacturers responsible for carrying out the control / analysis of the lots. Last Monday, February 21, the European Commission, with the agreement of the group of heads of Medicines Agencies (HMA), published some recommendations for the management of these operations.
Both the competent authorities of the Member States and the European Commission are aware that “there may be objective reasons why it is difficult to carry out the transfer of control of the lots to EU entities on the date of Brexit”.
For this reason and exceptionally, the AEMPS indicates that the possibility of granting the exemption from the obligation to carry out such batch control analyzes in entities located in the EU and allowing the release of the lots based on the recognition was considered. of quality control trials conducted in the United Kingdom, in duly justified cases and for a limited period of time.
Submission of applications
To this end, the Agency sets as conditions that the figure of the batch releaser of the marketing authorization must be located in EU27 / EEE29 on the date of the Brexit, that the release of lots must be supervised by a qualified person established in the territory of EU27 at the above-mentioned date and that the entity carrying out the control of the lots to be released in the territory of the EU27 / EEE29 must be verified by a competent authority of the EU27 / EEE29, including on-site verifications .
Marketing authorization holders who wish to benefit from the exemption and who fulfill all the conditions described above must request it before 29 March 2019 at the European Medicines Agency (EMA) for medicinal products authorized by the centralized procedure; to the Reference Member State (EMR) for drugs authorized by the European Mutual Recognition (RM) and Decentralized (DC) procedure and to the AEMPS for those authorized by national procedure.
In Distefar we echo this news.