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EMA news: pre-submission requests under Reg 2019/6, AMR updates and guidance for vaccine development

In the latest EMA news review there are updates on pre-submission requests under Reg 2019/6, AMR and guidance for vaccine development

The EMA has posted the press release with details of the CVMP's meeting of 16 – 17 February 2021, which includes the following important procedural announcement: 

For MA applications with a validation date on or after 28 January 2022, eligibility for the CP should be requested in accordance with Reg. 2019/6 and the correct legal base for the application under 2019/6 should be stated. Until the pre-submission form has been updated, Applicants should follow the more detailed instructions provided in the press release.

Further news from the February plenary meeting and other recent updates from the EMA are summarised below.

Antimicrobials and Resistance (AMR)

Maximum residue limits (MRLs)

A revised draft guideline on safety and residue data requirements for the establishment of maximum residue limits in minor species has been adopted.

Reg. 2019/6 and VMPs intended for Limited Markets

Under Reg. 2019/6, the term "Minor Use and Minor Species" is not used and instead there will be VMPs intended for limited markets.  Article 4(29) provides a definition of "limited market" and Article 23(1) provides the conditions to be met in order to be granted limited market status. The CVMP has now adopted further draft guidance on the eligibility criteria and and data requirements for limited market products. The following guidance is now out for consultation:

Also with respect to Reg. 2019/6, Issue 3 of "Veterinary Medicines Regulation highlights" has been published. This issue focuses mostly on developments on the various new union databases (manufacturers and wholesale distributors; product; pharmacovigilance), but also provides an overview of stakeholder views on what they expect to be the biggest impacts of 2019/6.

Relating to databases, the access policy for the Union Product Database has now been published, together with an overview of the comments received during consultation.

guidance for vaccines / immunologicals

Following their adoption in the January plenary meeting of the CVMP, the following documents have now been published on the EMA website:

Regulatory submissions

The EMA has published the latest version of Annex I to the SOP for management of PSURs for centrally authorised VMPs: contact details of NCAs for PSUR submission.

The dossier requirements for submission of MA and MRL applications to the EMA and to members of the CVMP has been updated.

An update version of “On-boarding of users to Substance, Product, Organisation and Referentials (SPOR) data services” has been issued.

 

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