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Posts Tagged ‘veterinary’

New Royal Decree with regards to the implementation of the Falsified Medicines Directive

May 9, 2019


On February 8, 2019, the Belgian Official Gazette published a Royal Decree amending both the Royal Decree of 14 December 2006 on medicinal products for human and veterinary use and the Royal Decree of 21 January 2009 concerning instructions for pharmacists.

The modifications that have been made with regards to the implementation of the Falsified Medicines Directive, include: “Without prejudice to Article 6septies, § 2 of the Act, the unique identification mark is included on the packaging of all reimbursable, non-prescription medicines whose reimbursement is not limited to delivery at the hospital.”

More information can be found here.

EU rules for batch testing of medicinal products after BREXIT

February 28, 2019

European Union

In light of the withdrawal of the United Kingdom from the European Union, the European Commission has published a letter on the rules for batch testing of medicinal products after the Brexit.

The competent authorities may allow marketing authorisation holders (MAHs), for a limited period of time and only in justified cases, to rely on quality control testing performed in the United Kingdom, under the following conditions:

  1. By the withdrawal date, a batch release site in the EU27 must be identified by the marketing authorisation holder.
  2. By the withdrawal date, the batch release site must be supervised by a qualified person established in the EU27.
  3. The establishment designated by the third party conducting the quality control testing may be verified by a competent authority of the EU27, including on the spot checks.
  4. All necessary steps must be taken to prepare the transfer of the quality control testing site from the United Kingdom to the EU27.

To make use of this “exemption”, affected MAHs must immediately notify the relevant national competent authority that granted the marketing authorisation (or EMA in case of centrally authorised products). This notification must detail the period of time and batches to be exempted and provide several commitments. It must be submitted without delay and in no case later than the 29th of March 2019.

After assessing whether a request is justified, the national competent authority or EMA can only grant the “exemption” for the time period strictly necessary and for the specific batches identified.  As MAHs are obliged to notify any issue that may cause disruption of supply to the competent authorities two months in advance, this means that if companies expect to encounter problems as of the withdrawal date, this notification needs to be done now.

Of note, in case the Withdrawal Agreement, which provides for a transition period, is ratified by EU Institutions and the UK, the MAHs will be able to continue to rely on quality control testing conducted in the UK until the end of the transition period. In that case, there will be no need for an exemption.

More information can be found here.

New EMA regulations 2019/5 and 2019/6

January 28, 2019

European Union

On January 7th, 2019 regulation 2019/5 was published in the Official Journal of the European Union “amending Regulation 726/2004, known as the Regulation on the Centralized Procedure. The new Regulation will apply from 28 January 2019.

Regulation 2019/5 combines and integrates the “key elements” of following rules into Regulation 726/004:

–       The rules on conditional marketing authorizations, currently contained in Regulation 507/2006

–       The rules on variations, currently in Regulation 1234/2008 (These rules have also been integrated in Directive 2001/83/EC)

–       The rules on financial penalties that may be imposed on marketing authorization holders of centralized authorizations, who fail to comply with their obligations, currently set out in Regulation 658/2007.

These consolidations are accompanied by several changes within these rules. In several cases, this new Regulation empowers the Commission to adopt new delegated acts that complement the “key elements” now contained in the centralized procedure regulation. In addition to these changes, this new Regulation also describes the financing of EMA.

Regulation 2019/6 removed the rules on veterinary medicinal products from Regulation (EC) No 726/2004 on the centralized procedure and the current Directive 2001/82/EG on veterinary products at national level was repealed.

This new regulation just entered into effect in all member states of the European Union. From now on, all parties involved have three years to ensure compliance with the obligations in this Regulation. The health authorities and all parties involved will make the necessary preparations, at both national and European level to ensure the implementation of this new regulation.

Regulation 2019/6, which will apply as of 28 January 2022, covers all the routes granting marketing authorization for veterinary products in the Union – both at centralized and national level. It should provide more innovation, increase the availability of veterinary medicines by simplifying the regulatory pressure and administrative burden and increase the competition in the veterinary pharmaceutical sector. In addition, a key point of this regulation is to strengthen existing EU laws against antimicrobial resistance. The safeguarding of public health, animal welfare and animal health and the protection of the environment remain the central focus point.

More information can be found here.



Revision of guidelines of veterinary medicines for MUMS

May 10, 2017


The Committee for Medicinal Products for Veterinary Use (CVMP) has updated the current guidelines on veterinary medicines for minor uses and minor species (MUMS). These revised guidelines provide more clarity on data requirements and include three guidelines explaining which data are required to demonstrate quality, safety and efficacy. The fourth revision concerns specific considerations for immunological veterinary medicines for MUMS. The guidelines point out in which cases data requirements can be reduced. Furthermore, they facilitate the determination of studies that are required for obtaining marketing authorization. This should stimulate the development of veterinary medicines and immunological products for MUMS, eventually leading to an improvement of animal health care.

More information can be found here.