KNOELL’S ANIMAL HEALTH REGULATORY UPDATE: JANUARY 2023
January 2023 has been an exceptionally busy month for European veterinary regulatory affairs:
Comprehensive updates have been made to regulatory reference information on many topics
A couple of important consultations have opened since the last knoell news update, with comments invited from industry, on subjects foreseen in Regulation 2019/6. Read on for the lowdown....
The EMA has published highlights from the CVMP meeting that took place on 17-18 January 2023:
- SAFETY - The Committee adopted a Q&A document on assessment and control of DNA reactive (mutagenic) impurities in VMPs
- EFFICACY - The Committee adopted a new reflection paper on resistance in ectoparasites
- NOVEL THERAPIES - The Committee adopted a draft revised guideline on quality, safety and efficacy of veterinary medicinal products specifically designed for phage therapy
- NEW VMP REG - The Committee adopted the guideline on the application of Article 34 of Regulation (EU) 2019/6 (classification of veterinary medicinal products - prescription status)
The adopted documents will be published on the EMA website in the coming weeks.
- A draft reflection paper was adopted for consultation in December, on environmental risk assessment of ectoparasiticidal VMPs used in cats and dogs. Comments are invited until March 31st 2023;
- Consultation has opened on a concept paper for a guideline on Risk Management requirements for elemental impurities in VMPs, including IVMPs, with comments invited until 31st March.
- The EMA’s 2023 Veterinary Info Day will take place online over two days on 16-17 February. More information and links to register are on the event page;
- Issue 57 of the SME Newsletter from the EMA’s SME Office is now available;
- The EMA Veterinary Medicines Division published a list of recommended due dates in 2023 for submission of the Pharmacovigilance Annual Statement (CAPs and non-CAPs);
- Revision 1 of the list of Member States' contact points for review of national translations of Quick Response (QR) codes of VMPs authorised via CP, MRP/DCP and nationally, has been published;
- EMA have updated the information relating to making payments on their website.
EMA have released a report jointly with EFSA, entitled Report on development of a harmonised approach to human dietary exposure. This is in view of proposed harmonisation of approach to residues in foods deriving from veterinary medicines, feed additives or pesticides. The overview of comments is also publicly available.
Antimicrobial sales reporting
- Part 1 of the data reporting protocol for Antimicrobial Sales and Use (ASU) - Reporting volume of sales - was published at the end of December. A reporting template is also provided.
- Part 2 of the data reporting protocol for Antimicrobial Sales and Use (ASU) - Reporting use data - was also published, with a reporting template.
The above documents are also available via the EMA’s ESVAC landing page.
CVMP Working parties
2023 Work programmes for the following CVMP Working Parties have been published:
- Scientific Advice;
- Environmental Risk Assessment;
- Novel Therapies and Technologies Working Party.
Certificates of medicinal products
A number of documents have been published or updated in January in relation to Certificates of medicinal products - applicable to veterinary and human medicines. This coincides with adoption of the WHO template for such certificates. Refer to the following on the topic:
- An Information package for Certificates of medicinal products;
- An Information note on the format and validity features of electronic certificates for medicines issued by EMA
- A user-friendly Information note on the topic of the online vertification system for electronic certificates;
- The application form to be completed for certificate requests;
- Instructions on how to fill the application form for such certificates
- A summary compilation of the changes to the certificate template, made to implement the WHO recommendations.
- Minutes of the Interested Parties meeting that took place in October 2022 have been published. The minutes include a summary of discussions on Article 13 or Regulation 2019/6 as it concerns local representatives and distributors, and national requirements for mock-ups.
- Version 3 of the CMDv Q&A document, List for the submission of variations according to Regulation (EU) 2019/6, was issued in December.
- The list of procedural contact points at the EU NCAs was updated in December.
Please note the Statement of the EU Vice-President Maroš Šefčovič on the movement of veterinary medicines from Great Britain to Northern Ireland, Cyprus, Ireland and Malta (extension of the ‘grace period).