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New EMA pilot project helps to facilitate validation of initial marketing authorisation applications

March 15, 2019


EMA launched a five-month pilot study to increase the correct submissions of initial marketing authorisations applications (MAAs). The pilot is a result of the 2016 EMA survey that showed validation issues occur in 90% of all initial applications.

The pilot study consists of an authomated checklist that will help companies assess the level of completion and consistency of the various sections in their application. EMA encourages applicants to submit the validation checklist as part of the MAA dossier. In addition, comments to the checklist may be sent to for further evaluation and improvement of the current validation process.

More information can be found here.

New report form for falsified medicines

March 15, 2019

The Netherlands

Since February, all prescription medicines have a unique code and sealed packaging. The purpose of these safety features is to detect counterfeit medicines in the regular distribution channel. Any problem with the code or the seal can be reported within 24 hours via the report form for falsified medicines.

More information can be found here.


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.

Practical recommendations for the new verification system against Falsified Medicines

February 12, 2019


In light of the Falsified Medicines Directive, that came into effect on 9th February 2019, FAMHP has issued practical guidelines for the handling of complications during the initial phase of the new verification system.

FAMHP and BeMVO have worked out an “alert”-procedure for when an issue arises during the scanning of a product. These guidelines describe the actions that need to be taken when an alert occurs. It is to be expected that numerous alerts and errors will pop up during the first weeks of operation of  this new verification system without evidence of a falsified product. Therefore, FAMHP has decided to introduce a transition period until 30th April 2019, during which the guidelines of circular letter 644 should be followed.

During this transition period, even though alerts occur during scanning, the pharmacist will still be allowed to deliver the product, provided that several requirements are met. These requirements are described in circular letter 644.

More information can be found here.


Liberalization of the Belgian Distribution Channel for Medical Devices: a New Royal Decree

January 29, 2019


On 28 January 2019, the new Royal Decree of 19 DECEMBER 2018 on the liberalization of the distribution channel for medical devices has been published in the Belgian Official Gazette. The new Royal Decree will come into force on 7 February 2019.

The most important changes imply that, as of 7 February 2019, the Belgian distribution channel for Medical Devices and Active Implantable Medical Devices is no longer restricted to (hospital) pharmacies. From that date, patients and healthcare professionals can purchase medical devices, such as sterile bandages or physiological serum, directly from any distributor, from pharmacy to supermarket, and even directly from the manufacturer. The distribution of medical devices will also be facilitated for laboratories, nursing homes and private clinics.  This liberalization should ensure that the access of end-users and patients to medical devices is better aligned with the principles of free movement of products with CE Marking within Europe. Nevertheless, the liberalization shall have no impact on the safety or efficacy of the medical devices on the Belgian market and does not affect the reimbursement conditions set by the RIZIV/INAMI.

In Belgium, all distributors and exporters must be registered with the FAMHP. For manufacturers, there is currently no direct obligation to register.

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.



Changes in formulation and content of several codes from ‘The guidelines of the inspection board’ in the Netherlands

January 28, 2019

The Netherlands

After revision of the code for public advertising and medical self-care tools (CPMH), the code for the promotion of health products (CAG) and the code for advertising of medicines (CPG), various adjustments were made:

To make the codes more understandable, multiple changes were implemented to the content and the standards in commandment and prohibition were simplified. Most changes were made to the CAG to align this code with the CPMH and CPG. The most important adaptations were (1) the integration of provisions from the Claims Regulation and (2) the integration of the Database Claims Regulation and the guidance document. In addition, the CAG will most likely become part of the Dutch Advertising Code as of 1 February 2019, just as CPG and CPMH are already part of the Dutch Advertising Code today.

The adjusted codes are available on the inspection board website and have been in effect since the 1st of January 2019.

More information can be found here.


New approved disclaimers for health claims for botanicals

January 28, 2019

The Netherlands

The Dutch inspection board published a new list of disclaimers for botanicals that can be used immediately after a health claim. If the disclaimer only applies to a part of the health claim, an asterisk may indicate this. To assure the readability and to prevent confusion, the disclaimer does not have to be mentioned after the shortened health claim on the front of a package.

The list, in use since the 1st of January 2019, includes the following disclaimers:
– Health claim awaiting approval by the European Commission
– Authorization procedure for this health claim is still ongoing
– Evaluation of the health claim is ongoing
– Health claim pending European authorization
– Evidence for this health effect is still being assessed in European authorization procedure
– The health effect has not yet been officially established

Pre-existing approvals for advertisements with botanical claims remain valid until the end of the validity of the approval. Entries without validity period (e.g. packaging), must comply with this the 1st of January 2020 at the latest.

If the advertiser himself can substantiate the claim and does not want to mention a disclaimer, the Inspection Board, together with the Advertising Code Committee, will examine which criteria apply.

More information can be found here.


Guidelines on the safe use of essential oils in food supplements

January 8, 2019


The French Directorate General for Competition, Consumption and Fraud Prevention (DGCCRF) has published guidelines for the safe use of essential oils in food supplements. These guidelines include a list of plants containing essential oils that can be used for human consumption. Two additional lists of plants are added containing essential oils that are not permitted in food supplements.

The list with permitted essential oils has no legal force. In addition, the list is not exhaustive. Any essential oil derived from plants that is not included in the list yet, can be added through demonstration of their traditional use for human consumption. For this, relevant data should be collected from the literature and sent to the 4A office of the DGCCRF. Of note, if an essential oil is included in the positive list, it is still possible that additional precautions should be taken for its safe use. These recommendations are listed in an additional guidance document provided by the Directorate-General.

More information can be found here.