Veterinary medicinal products regulation

Regarding implementation of the new regulation „European Parliament and of the Council of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/EC“

The New veterinary Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/EC will apply from 28 January 2022 and repeals Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products.

For smooth transition from the provisions of the Directive to the implementation of the requirements of the new Regulation the European Commission has recently published a ”Commission Notice on marketing authorizations for veterinary medicinal products for which the expiry of the 5-year period of validity falls on or after the date of entry into application of Regulation (EU) 2019/6“ (2021/C 274/02).

With this notice, the European Commission aims to assist businesses and national competent authorities in applying the relevant legislation. The purpose of this Notice is to inform stakeholders on how the Commission intends to deal with centrally authorised veterinary medicinal products for which the expiry of the 5-year period of validity of the marketing authorisation falls on or after 28 January 2022. The Notice also addresses certain questions that may arise in relation to nationally authorised products.

The Co-ordination group for Mutual recognition and decentralized procedures-Veterinary (CMDv) prepared Transitional arrangements for the entry into application of Regulation (EU) 2019/6 for veterinary medicinal products registered under national, mutual recognition and decentralised procedure. This will help both national medicines agencies and registrants to implement the provisions of the Regulation, as this document is constantly updated and a link needs to be opened (https://www.hma.eu/fileadmin/dateien/Veterinary_medicines/CMDv_Website/Implementation_of_the_VMP_Regulation/CMDv_QA_on_transitional_arrangements_July_2021.pdf) for the latest information.

The State Food and Veterinary Service (hereinafter – SFVS) also follows the provisions of the above-mentioned documents. Currently, the marketing authorization for a veterinary medicinal product issued in accordance with Directive 2001/82 is valid in Lithuania for 5 years.

In order to implement the provisions of the Regulation on variations to the authorization of veterinary medicinal products from limited period 5 years for an unlimited period, the SFVS will issue a marketing authorization for veterinary medicinal products registered under the national, mutual recognition, and decentralised procedures according to these steps:

•   if the validity of the registration of the veterinary medicinal product is 5 years and the term expires in 2022 on or after 28 January – the Marketing authorization holder (hereinafter – MAH) has to apply for renewal only if the application date (6 months before the registration expires) is before 2022 January 28. These renewal applications will be processed in accordance with Directive 2001/82/EC;

•   if the validity of the marketing authorization of the 5 years term expires after 2022 January 28 and the filing date for renewal application registration is after 2022, applications for renewal are not required. The MAH must inform the SFVS in advance (6 months ago) by e-mail: vaistu.registracija@vmvt.lt  whether or not it wishes the registration of the veterinary medicinal product to be extended indefinitely. In this case, the MAH does not provide any additional documentation.

If the MAH does not submit an application for renewal, or will not inform in advance of the request to issue indefinite marketing authorisation of the registration of the veterinary medicinal product, the registration certificate of the veterinary medicinal product shall be valid until the date currently specified therein.

Update of QRD templates

The SFVS informs that by 29 January 2027, the MAH must update the SPC, labelling and package leaflet (product information) of veterinary medicinal products. The variations must be completed and implemented in the printed package leaflet and on the label of the veterinary medicinal product by 27 January 2027.

European Medicines Agency‘s (EMA) Committee for Medicinal Products for Veterinary Use (CVMP) adopted a joint EMA/CMDv guidance on the details of the classification of variations requiring assessment according to Article 62 of Regulation (EU) 2019/6 for veterinary medicinal products and on the documentation to be submitted pursuant to those variations (EMA/CMDv/190673/2021).

Following the endorsement by the Heads of Medicines Agencies, the document will be published on the Agency’s website in due course.

Based on the clasification provided within the above guidance, a variation requiring assessment clasifyes as G.I.18, should be submitted in order to update curent PIs in line with the QRD version 9. Grouping with other variations in chapter G affecting the PI texts for the same product is recommended.

The SFVS anticipates that it may receive a large number of these variations at one time, which may make it difficult to assess them. In such a situation, it is planned to propose an exchange at a time acceptable to both parties.

Transition from PSURs to signal management and from DDPS to PSMF

The SFVS will follow the guidelines as outlined in the Transitional arrangements for the entry into application of Regulation (EU) 2019/6 for veterinary medicinal products registered under national, mutual recognition and decentralised procedure. This will help both national medicines agencies and registrants to implement the provisions of the Regulation, as this document is constantly updated and a link needs to be opened (https://www.hma.eu/fileadmin/dateien/Veterinary_medicines/CMDv_Website/Implementation_of_the_VMP_Regulation/CMDv_QA_on_transitional_arrangements_July_2021.pdf) for the latest information.

Additional information is available on the blogs of the European Medicines Agency (EEA) and the European Commission (EC):

European Medicine Agency: Q&A renewals

European Medicine Agency: Product information template v.9

European Commission: Commission Notice on marketing authorizations for veterinary medicinal products for which the expiry of the 5-year period of validity falls on or after the date of entry into application of Regulation (EU) 2019/6 (2021/C 274/02) 

European Commission: Implementation of the Regulation

Head of Medicines Agencies (HMA): ongoing public consultation

 

 

 

 

 

 

Published:
2021-08-16
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