Swiss authorised representative (CH-REP)

If the manufacturer of a medical device does not have its registered place of business in Switzerland, its products may only be placed on the market once an authorised representative domiciled in Switzerland has been appointed. This also applies to manufacturers with their registered place of business in the EU. You may find all the information in the following information sheet.
June 23, 2021

Information note on the format and validity features of electronic certificates for medicines issued by the European Medicines Agency

EMA has implemented a new system to issue electronically signed and authenticated certificates for human and veterinary medicines on March 30, 2020.
The aim of this ´Questions and Answers´ document is to provide guidance on the format of the electronic certificates issued by EMA, the safety features supporting their authenticity and integrity as well as the Agency´s measures to support the regulatory authorities of importing countries for confirming their validity, in case of any doubt.
June 14, 2021

EDQM releases guidance on paper and board materials and articles for food contact

The European Directorate for the Quality of Medicines & HealthCare (EDQM) has published the first edition of the technical guide entitled “Paper and board used in food contact materials and articles”. This guidance document is expected to improve the protection of consumers against contaminants (metals, antioxidants, stabilisers, etc.) potentially released by materials in contact with food (packaging, containers, plates, cups, straws, etc.). It also aims to support the harmonisation of regulatory approaches to consumer health protection across Europe.
May 20, 2021

AIFA communication on the management of reports of lack of efficacy in the National Pharmacovigilance Network

The Italian Medicines Agency (AIFA), in line with what is written in Guideline on good pharmacovigilance practices (GVP) Module VI – Collection, management and submission of reports of suspected adverse reactions to medicinal products (Rev 2) and in the Ministerial Decree April 30, 2015, intends to provide details on the management within the National Pharmacovigilance Network (RNF) of the reports of suspected adverse reactions related to lack of efficacy.
May 13, 2021

EMA regulatory update for Signal Detection May 2021

EMA recently released draft agenda for “Pharmacovigilance Risk Assessment Committee (PRAC)” meeting conducted in between 03 May 2021 to 06 May 2021 for the assessment of new signals detected from new sources. Assessment for important items are from Item no. 02 to Item no. 09.
May 7, 2021

Update on the Ph. Eur. policy on elemental impurities – Monographs on substances for veterinary use only

Since 1 January 2021, new marketing authorisation applications for such products submitted in the European Union must comply with these requirements and all veterinary medicinal products will have to comply by January 2023. The European Pharmacopoeia is proposing to delete the cross-references to the test for Heavy Metals (HMs, general chapter 2.4.8) in the 16 monographs on substances “for veterinary use only”.
May 5, 2021