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Medicines for Europe


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EFPIA – European Federation of Pharmaceutical Industries and Associations


EFPIA Newsletter 08 July 2021 





EDQM's Experience with Real-Time GMP Remote Inspections

"Innovation overcoming adversity". This is the title of a publication by the European Directorate for the Quality of Medicines & HealthCare (EDQM) on the topic of "Real-Time Remote Inspections" (RTEMIS).



Q&A Document on Nitrosamine Impurities Updated

The latest revision of the EMA's question and answer document on nitrosamine impurities in medicinal products includes clarifications of some important issues. Read more here about the requirements for reporting nitrosamine impurities to regulatory authorities and the current deadlines for this.



BfArM starts Sale of medical Cannabis "Made in Germany"

The moment has finally come: The BfArM has started the state sale of medical cannabis from German cultivation. However, importation remains possible.



Brexit: EU defines possible Solutions for Northern Ireland

For medicines, the solution involves the "EU changing its own rules so that regulatory compliance functions for medicines authorised by the UK for the Northern Ireland market, in accordance with the Protocol, may be located in Great Britain, subject to specific conditions ensuring that the medicines concerned are not further distributed in the EU Internal Market. 


List of centrally authorised products requiring a notification of a change for update of annexes (22/06/2021)

Parallel distributors are only required to inform the EMA of changes to the labelling or leaflet related to any update of the annexes of marketing authorisation once a year in their annual update application, except in cases related to safety or quality issues. The following table lists the centrally authorised products for which the EMA requires notifications of safety update before implementation.





Implementation of the European Pharmacopoeia Supplement 10.6 – Notification for CEP holders

‘’Supplement 10.6 of the European Pharmacopoeia (Ph. Eur) is now available. CEP holders are invited to update their applications according to the revised monographs that will be implemented on 1 January 2022, and to follow the instructions given below.’’



Highlights of 2020 – EDQM annual report now available

The 2020 annual report of the European Directorate for the Quality of Medicines & HealthCare (EDQM) is now available, providing a comprehensive overview of its activities, achievements and events.





Q&A: Renewals (updated)


Other: Timetable: Non-safety referrals



Other: Timetable: Safety referral (Article-20 and Article-31 pharmacovigilance)


Other: Timetable: Safety referral (Article 107i, urgent Union procedure)



Procedural timetables (updated)



Periodic safety update single assessment: Sultamicillin - List of nationally authorised medicinal products - PSUSA-00002829-202011



Minutes: Minutes of the CHMP meeting 17-20 May 2021 (9/07)



Mandatory use of ISO/ICH E2B(R3) Individual Case Safety Reporting in the EU: Hands-on Training Course using the EudraVigilance System



Nitrosamine impurities (updated):



Referrals document: Nitrosamines EMEA-H-A5(3)-1490 - Questions and answers for marketing authorisation holders / applicants on the CHMP Opinion for the Article 5(3) of Regulation (EC) No 726/2004 referral on nitrosamine impurities in human medicinal products (updated)  



Template or form: Step 2 - Nitrosamine detected above acceptable intake or new nitrosamine detected response template (updated)



Template or form: Step 2 - Nitrosamine detected response template (updated)





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UPDATE - CMDh practical guidance for Marketing Authorisation Holders of nationally authorised products (incl. MRP/DCP) in relation to the Art. 5(3) Referral on Nitrosamines



UPDATE - Template for requests for RMS in a DCP for medicinal products for human use



UPDATE - CMDh position paper on the use of Mobile scanning and other technologies to be included in labelling and PL in order to provide information about the medicinal product



UPDATE - Step 2 - Nitrosamine detected above acceptable intake or new nitrosamine detected response template



UPDATE - EMA/CMDh Q&As on the implementation of the Medical Devices and In Vitro Diagnostic Medical Devices Regulations





Information Paper regarding the Use of ISO IDMP Standards in ICH E2B(R3) Messages

The information paper explains the current situation about the International Organization for Standardization (ISO) standards related to the identification of medicinal products (IDMP) that are used in E2B(R3) messages (as of 16 February 2021).

The Information Paper and further information can be found on the E2B(R3) Individual Case Safety Report (ICSR) Specification and Related Files webpage.







Conclusões do Conselho sobre o acesso a medicamentos e dispositivos médicos para uma UE mais forte e resiliente



Novo Regulamento dos Dispositivos Médicos: ficha informativa para o ecossistema de aquisição

Documento em anexo



Relatório de Farmacovigilância: monitorização da segurança das vacinas contra a COVID-19 em Portugal



Atualização da lista de medicamentos cuja exportação é temporariamente suspensa

Circular Informativa n.º 077/CD/100.20.200 de 01/07/2021

Deliberação n.º 068/CD/2021 atualiza a lista de medicamentos cuja exportação é temporariamente suspensa.



Lista de medicamentos cuja exportação é temporariamente suspensa

Atualizada pela Deliberação n.º 068/CD/2021, de 25 de junho.


Lista em vigor a partir de 2 de julho 2021



Nota explicativa sobre o período transitório aplicável aos produtos cosméticos importados do Reino Unido


Como referido na Circular Informativa n.º 036/CD/550.20.001, de 22/03/2021, relativa ao período transitório excecional de seis meses aplicável aos produtos cosméticos importados do Reino Unido, verificou-se que “… algumas das empresas cuja Pessoa Responsável anteriormente se encontrava sediada no RU, e cujos produtos pretendem neste momento ser importados para o mercado nacional, não tiveram em atenção a necessidade de uma adequada instrução do processo de importação, nomeadamente com informação relativa à segurança do produto o que inclui determinadas análises laboratoriais.”. (…)


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