KNOELL’S ANIMAL HEALTH REGULATORY UPDATE: APRIL 2023
A handful of reference documents were issued or revised in April, and a consultation opened late March. Act quickly if you want to join the webinar taking place on 24th April, and those involved in bacteriophage development are invited to engage with EMA.
Highlights from the CVMP meeting that took place on 21-22 March are now available, as are the agenda and highlights from the meeting on 18-20 April. Highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) meeting that took place 11-14 April 2023 are now available via this page.
- Consultation has opened on a draft Guideline on quality aspects of pharmaceutical VMPs for administration via drinking water - Draft annex on compatibility studies between VMPs and biocidal products. Comments are invited until 30th June.
- The Commission issued a final decision in March, applicable EU-wide, following conclusion of the referral procedure for VMPs containing N-methyl pyrrolidone (NMP) as an excipient.
EVENTS AND TRAINING
- A Volume of sales webinar for Union Product Database industry users will take place on 24th April 2023. Registration is via this page;
- Developers of bacteriophage technology are invited to express their interest in attending the Novel Therapies and Technologies Working Party (NTWP) Focus Group online meeting on 11th May 2023.
- CVMP have issued a Q&A document on describing adverse events in the product information (SPC and PL);
- Contact points at the Member States for communication of pharmacovigilance alerts by MAHs are listed in this document issued by EMA;
- The EMA have updated their fees for applications, with updated tariffs applicable from 1st April 2023;
- An updated version (2.13) of the IRIS guide to registration and Research Product Identifiers (RPIs) has been published;
- EMA has created a new page on Avian Influenza;
- A news item has been published on Reducing risks to human and animal health from exposure to N-methyl pyrrolidone in veterinary medicines;
- The VeDDRA dictionary has been updated (Link to Excel file).
- The CMDv page on SPC harmonisation has been updated to include a request form for MAHs who wish to participate in the SPC harmonisation exercise in 2024: response due by 31st May. More details here.
- The CMDv has published a Q&A document on classification of teat dips in the Member States.
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