Clarification on the submission of changes to the AIC

The Italian Medicines Agency AIFA provides some clarifications to all pharmaceutical companies regarding the submission of changes to the AIC. These clarifications concern the changes presented according to the national, mutual recognition/decentralized (MR/DC) procedure pursuant to EC Regulation No. 712/2012 and in line with the new “classification guidelines” of the European Commission dated 16/05/2013. The objective is to favor the correct presentation by companies of applications concerning changes to the AIC. You can find enclosed the update of the Explanatory Note of the AIFA Resolution of 25 August 2011.
August 4, 2021

Reflection paper on Good Manufacturing Practice and Marketing Authorisation Holders

The European Medicines Agency issued an updated reflection paper specifying the good manufacturing practice (GMP) responsibilities of marketing authorization holders under the European Commission GMP guidelines and other EU legislation. In general, these responsibilities range from responsibilities that relate to outsourcing and technical agreements, to ones that require the MAH to perform certain specific tasks. These responsibilities are spread over the various chapters and annexes of the GMP Guide, and are quite numerous.
August 2, 2021

Guideline on quality documentation for medicinal products when used with a medical device

The European Medicines Agency (EMA) has adopted a guideline on the quality information that manufacturers of combination products should submit in marketing authorization applications. This guideline focuses on product-specific quality aspects of a medical device, or device part, that may have an impact on the quality, safety and/or efficacy of a medicinal product and outlines where this information should be placed in the Common Technical Document. The guideline should be read in conjunction with the Q&A on the implementation of the MDR.
July 27, 2021

New guidance on authorisations and procedures required for importing Investigational Medicinal Products to Great Britain from approved countries

IMPs imported into Great Britain from a country on the ‘approved country for import’ list that have been QP certified in a country on the list will not require recertification in Great Britain. From 1 January 2022 a UK Manufacturing and Import Authorisation (MIA(IMP)) will be required to verify that these IMPs have been certified by a QP in a listed country (the ‘oversight process’). The new guidance describes what existing authorisation holders and new applicants should do to put procedures in place for the oversight process and how to apply for the required authorisation.
July 13, 2021

EDQM “RTEMIS” pilot project: real-time remote GMP inspections of API manufacturers

Interruptions to the inspection programme of the European Directorate for the Quality of Medicines & HealthCare (EDQM) due to travel restrictions (necessary by the COVID-19 pandemic) led to the creation of a system of Real-Time Remote Inspections (RTEMIS). The pilot project combines a live video feed, linking inspectors and manufacturing sites of active pharmaceutical ingredients (APIs), and the review of documentary sources. The objective is to monitor compliance with both Good Manufacturing Practice (GMP) and applications for certificates of suitability for European Pharmacopoeia (CEP) monographs at production sites. July 8, 2021

EU IDMP Implementation Guide – version 2.1

EMA released version 2.1 of the EU IDMP Implementation Guide (EU IG v2.1) in June 2021. It provides standardised definitions for the identification and description of medicinal products for human use. The new version supports the implementation of Product Management Service (PMS) Step 1 and data submission on medicinal products authorised under the centralised procedure.
July 5, 2021

GOOD PRACTICES FOR DATA MANAGEMENT AND INTEGRITY IN REGULATED GMP/GDP ENVIRONMENTS

The PIC/S Guidance on Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments (PI 041-1) has entered into force on 1 July 2021. The guidance has been developed primarily for inspectors, but also serves as a valuable resource for industry to provide clarity on areas of greatest risk and regulatory expectations. It marks the completion of significant effort by PIC/S Participating Authorities over an extended period of collaboration to address an area of significant industry and regulatory interest. The feedback received by professional associations across the pharmaceutical industry was highly valuable in identifying opportunities to further clarify regulatory interpretations and also collate topics for future revisions.
July 5, 2021

Highlights from the second meeting of the Nitrosamine Implementation Oversight Group (NIOG)

The Nitrosamine Implementation Oversight Group (NIOG) was set up by the European medicines regulatory network to oversee the harmonised implementation of the Article 5(3) CHMP opinion on nitrosamines in human medicinal products. The NIOG will be the main interface between regulators and industry to agree on topics requiring further scientific discussion. Click on the bottom to know more about the second meeting of the NIOG. The next meeting is expected to take place in September 2021.
June 30, 2021

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