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Posts Tagged ‘EU’

EU-US Mutual Recognition Agreement for inspections

May 8, 2019


With the Mutual Recognition Agreement between Europe and the US, inspections are to be mutually recognised in the future. The FDA’s approval of the EU Member States proceeds successively. Two more countries have recently been approved: Bulgaria and Cyprus. That makes 24 approved EU states so far. There are 4 countries left: Germany, the Netherlands, Luxembourg and Slovakia. By 15 July, 2019 though, all authorities and countries are supposed to have been reviewed and approved. Regular updates may be found in a question and answer document on the EMA’s website.


March 13, 2019


As from March 30, 2019, the United Kingdom (UK) will no longer be a member of the European Union (EU). Although to date, no agreement between the EU and the UK has been approved, the companies involved in Brexit should anticipate the consequences as much as possible.

As a result of Brexit, new import and export rules will enter into force within a certain period and under conditions that are currently still to be defined. The Belgian Federal Agency for the Safety of the Food Chain (FASFC) will have to carry out import and export controls, mainly focusing on products that pose a risk in the areas of plant health, animal health and food safety. Companies that want to export to the UK or import from the UK must be aware of this and take this into account. If the EU and UK reach an agreement on Brexit, a transition period will apply until the end of 2020 in which all current European rules for the UK remain applicable.

A Belgian portal site on Brexit ( has been made available so that companies can easily access all useful information in the context of Brexit. On this National portal, the FASFC also provides a specific FASFC site for companies and a contact centre to support the companies involved as well as possible.

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 EU GMP directive

October 18, 2018


The European Union (EU) has published its new directive for manufacturers of pharmaceutical products. This directive replaces the existing directive (Directive 2003/94/EC) on medicinal products for human use. The new EU Good Manufacturing Practice (GMP) directive, Commission Directive (EU) 2017/1572, came into effect on 31 March 2018. The new EU GMP Directive removes all aspects of the manufacturing of medicines for research which will make the Directive on finished products easier to read. The manufacturing of medicines for research will become subject to separate legislation, namely Regulation 2017/1569. The new EU GMP Directive has a similar structure as the existing one and many of the requirements remain the same.

This new EU GMP Directive was transposed into Belgian law via the Royal Decree of 27 June 2018, amending the RD of 14 December 2006.

New Swiss legal regime on food supplements expands the market

September 28, 2017

Switzerland and EU

Switzerland has updated its legal regime on food supplements (FS) resulting in a better alignment with the food regulations applicable in the European Union (EU). These new rules facilitate marketing of FS originating from EU member states in Switzerland and vice versa. As a consequence, drastic changes to the products are no longer needed and authorization procedures have become less complicated. In addition, the Swiss orders on food labeling and claims and the use of food additives have been revised. These are now almost fully in agreement with EU regulations.

FS legislation in EU did not reach full harmonization between all member states. For example, each EU member has set its own maximum levels for nutrients and has its own rules on the use of botanical preparations and other substances. As a result, Switzerland also maintained its own maximum levels for vitamins and minerals. These, however, are in line with the EU trend.

One of the major benefits of targeting the Swiss market is the absence of the obligation to register or notify FS. Together with the fact that the new legislation is now more or less in line with EU regulations, it makes commercialization in Switzerland very attractive as it is not accompanied by additional notification burdens or costs. However, verification of compliance of a FS’s composition and labeling remains necessary when introducing the FS onto the Swiss versus EU market.

More information can be found here.

Update of MRA between EU and US

April 14, 2017


The European Commission and the United States Food and Drug Administration (FDA) have updated the EU-US 1998 Mutual Recognition Agreement (MRA). According to this amendment, the EU and US regulatory authorities now mutually recognize inspections of pharmaceutical manufacturing facilities.

The aim of this MRA is to avoid the duplication of inspections, to lower inspection costs and to enable regulators to devote more resources to other parts of the world where there may be greater risk.

The MRA states that by November 2017, FDA must have assessed authorities in eight EU countries and that FDA’s assessment of all of the EU national agencies has to be completed by July 15th 2019.