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Update: UK has left the EU
After the agreement that regulates the United Kingdom's withdrawal from the European Union (EU) on January 31, 2020 has been signed and ratified by both the British Parliament and the European Parliament, the European Council has decided on the conclusion of the Withdrawal Agreement accepted on January 30th, 2020. From 01.02.2020, the United Kingdom will therefore be considered a third country. The agreed transition period until December 31, 2020, during which the conditions and obligations of the Acquis Communautaire continued to apply to the United Kingdom, has also expired and will not be extended. Due to the Ireland / Northern Ireland Protocol, which has been in force since January 1st, 2021, the obligations from the Acquis Communauitaire for Medicinal Products continue to apply to Northern Ireland.
For more information, see:
European Commission: Getting ready for the end of transition period
European Commission: Relations with the United Kingdom
Effects of Brexit on approved drugs and ongoing proceedings under the responsibility of the BfArM
After the so-called Brexit, the UK Medicines and Healthcare Products Regulatory Agency, MHRA and Veterinary Medicines Directorate (VMD) are expected to be in place in the UK - with the exception of NI approvals under the Northern Ireland Protocol (NIP) - no longer available for drug approval procedures within the EU
The primary goal of the BfArM is to maintain the availability of drugs for patients. The BfArM has further strengthened its role in the European network, increased its capacities to take on additional centralized and decentralized (MRP / DCP) approval and follow-up procedures and has also become more involved in the areas of clinical trials and inspections as well as pharmacovigilance in order to address bottlenecks in the European regulatory Compensate network as best as possible.
The BfArM sees itself as a "full provider", i.e. the capacities are created for all additional tasks so that procedures can be taken over without restrictions for all areas of indication.
At the European level, working groups on the subject of “Brexit” have been established in all committees, which publish timely and updated European specifications on the relevant websites:
The BfArM fully supports the information already provided and the specifications made at European level.
The BfArM particularly draws attention to the fact that the following persons or activities must be located within the EU or the EEA in order for medicinal products to be marketed in the EU:
- Marketing authorization holder and applicant
- Batch control and release
- Qualified person (QP)
- Qualified person for pharmacovigilance (QPPV)
- Graduated plan officer (in an EU country)
- Pharmacovigilance System Master File (PSMF)
The transfer of the above-mentioned persons and activities to the EU or the EEA should have taken place before January 01, 2021. In ongoing DCP approval procedures, however, the corresponding changes can also be submitted after 01.01.2021 with the day 106 or day 160 response. In ongoing MRP procedures, only a change of the applicant or the future MAH with the day 40 response is possible, all other changes must be applied for and completed by variation before the start of the MRP.
As of 01/01/2021, medicinal products for which at least one of the above persons / activities is located exclusively in Great Britain (exception: batch control and batch release may take place in NI) are no longer EU-compliant and may no longer be in the EU / EEA in Be brought into circulation. Goods that have already been released and for which the above-mentioned persons or activities are still located in Great Britain, but which were placed on the market in the UK, the EU or the EEA before January 1, 2021, may remain on the market. New goods for which the above persons or activities are still (exclusively) located in Great Britain after December 31, 2020 may no longer be marketed in the EU or the EEA from January 1, 2021. Third country regulations then apply to imports from Great Britain - the details of the trade agreement between the EU and Great Britain must be taken into account.
Marketing authorization holders are reminded to familiarize themselves with the requirements of the Northern Ireland Protocol and to update their marketing authorizations if necessary. For all ongoing procedures and granted approvals in the MRP / DCP, in which UK is currently still CMS, there is an automatic transfer from UK to XI (official term for Northern Ireland). Applicants or marketing authorization holders who do not wish to make use of this automatic transfer should inform the MHRA and the RMS immediately. For the BfArM, this information should be sent to the email address [email protected]
According to the protocol, the UK's national marketing authorizations for Northern Ireland (i.e. other than the centralized marketing authorization procedure) must comply with Articles 17 and 18 of Directive 2001/83, i.e. they must use the decentralized procedure (DCP) or the procedure for future marketing authorizations of mutual recognition (MRP) if the applicant already has authorization in one EU / EEA member state (MRP) or applies for authorization in more than one EU / EEA member state (DCP). Therefore, in the above situations, applicants seeking UK approval in relation to Northern Ireland must include Northern Ireland as a Member Country (XI) in their application for approval in the DCP or MRP.
Further information on the IE / NI protocol can be found in the "Notice to stakeholders - withdrawal of the United Kingdom and EU rules for medicinal products for human use and veterinary medicinal products" published by the European Commission in March 2020, as well as in the CMDhGuidance on the NIP. The CMDh has put together further questions on the consequences of Brexit in a separate guidance. All documents mentioned here can be found on the CMDh website under “Brexit”.
The trade agreement between the EU and Great Britain concluded on December 24th, 2020 includes, among other things, an agreement on the mutual recognition of inspections and GMP documents.
Further questions on the subject of “Brexit” can be sent to the BfArM by e-mail: [email protected] Requests to change the RMS can be sent to the email address [email protected] using the CMDh template.
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