This guidance is intended to explain the practice of Articles 60 to 68 of Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on #veterinarymedicinalproducts, laying down rules for the placing on the market, manufacturing, import, export, supply, distribution, pharmacovigilance, control and use of veterinary medicinal products and to categorise the variations requiring assessment.
The Annex to this guidance provides a list of variations, which require assessment according to Article 62 of Regulation (EU) 2019/6 and indicates, where appropriate, the timetable proposed to be applied, the data to be submitted and how this data should be documented.
The Annex to this guidance will be regularly updated, taking into account the recommendations provided in accordance with section 7 of this guidance as well as scientific and technical progress.
The objective of this guidance is to provide details on variations requiring assessment, i.e. those not listed in the Commission Implementing Regulation (EU) 2021/17 of 8 January 2021 establishing a list of variations not requiring assessment in accordance with Regulation (EU) 2019/6 of the European Parliament and of the Council, hereafter referred to as the Implementing Regulation.
According to Article 62(1) of Regulation (EU) 2019/6, where a variation is not included in the Implementing Regulation, the #marketingauthorisationholder shall submit an application for a #variation requiring assessment to the competent authority which has granted the marketing authorisation or to the Agency, as applicable.
This guidance is intended to
• establish a specific veterinary variation guidance;
• introduce, for variations requiring assessment according to Article 62(1) of
Regulation (EU) 2019/6, a variation code system and its documentation requirements;
• utilise existing knowledge to include all known variations;
• identify variations that fundamentally alter the terms of the marketing authorisation and that can either be granted a marketing authorisation or be included in the initial marketing authorisation to which it relates (changes of active substance(s), strength, pharmaceutical form, route of administration or food producing target species);
• reflect the different levels of complexity of variations requiring assessment, as such generally enabling shorter assessment timetables for less complex variations and longer timetables for changes of active substance(s), strength, pharmaceutical form, route of administration or food producing target species and other more complex variations.