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Posts Tagged ‘medicines’

New measures to limit the unavailability of medicines – Impact on professional stakeholders

June 7, 2019


On 18 May 2019, a new law amending the law of 25 March 1964 on medicines entered into force. This amendment should reduce one of the causes of the temporary unavailability of certain medicines for Belgian patients. It intends to do so by preventing that medicines, supplied in the context of the fulfilment of public service obligations, intended for Belgian patients, are distributed to other countries.

The letter published by FAMHP provides an overview of the practical impact for the stakeholders involved and can be found here.

More information about the amendment of the law can be found here.

Healthcare Transparency Register concept law

May 14, 2019

The Netherlands 

On 30 April 2019, the concept text for the Healthcare Transparency Register law was presented for consultation. With this concept law, the obligation for suppliers of medicines and medical devices to report financial relationships with healthcare professionals and patient organizations to the Healthcare Transparency Register becomes legally anchored.  

The concept law anticipates the evaluation of the Healthcare Transparency Register that is currently being carried out by the Institute for Rational Use of Medicine. The results of this evaluation are expected by the end of this summer. 

The Healthcare Transparency Register Foundation will study the concept law and involve it in the results of the evaluation.


Google Ads as unacceptable advertising

May 14, 2019

The Netherlands

In the Netherlands, the court has ruled on a case in which a medical search term led to a Google Ad for a food supplement. The court decided that this is unacceptable publicity for medicines.

The Google Ad for the food supplement appeared after typing in a medical search term.  Although the advertising agency had been explicitly instructed otherwise, the Google advertising did appear after typing in the medical search term. The court judged that this was not sufficiently supervised by the advertising agency.

The court ruled that the advertiser was in violation of the Medicines Act, by advertising on the internet for unregistered medicines. In this case, the unregistered medicine was the food supplement, positioned as a medicine by the medical search term.

With fines around 140.000€, it is of interest to know search terms are considered an integral part of a Google advertisement and excluding certain search term categories does not shield an advertiser from a possible violation. Therefore, it is advised to exclude a list of exact keywords and present this as such to KOAG/KAG for approval.

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.

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.


Safety features for medicinal products for human use – Questions and Answers – Versions 11 & 12

December 12, 2018


Versions 11 & 12 of the Q&A on Safety features for medicinal products for human use have been published in October and November of 2018. Following these updates, multiple questions have been revised (1.20; 1.23; 2.21; 7.15; 8.4; 8.7) and some new questions have been added (5.8; 6.8; 8.8).

Compared to the previous version, the placing of safety features by means of stickers has been defined more in detail. Stickers must be placed under GMP conditions and the outer packaging on which the identifier is placed as a sticker must meet all applicable labelling requirements. Moreover, the use of stickers is not acceptable when the readability of compulsory regulatory information is limited.

More information can be found here.

Finally, clear provisions on the fiscal importation of medicines from third countries

February 12, 2018


It is not allowed for Wholesaler’s Distribution Authorization (WDA) holders to purchase medicines from companies based outside the European Economic Area (EEA) if these medicines were manufactured within the EEA and released by the qualified person of the batch releaser in the EEA, so when the medicines did not leave the EEA physically nor underwent any manufacturing operation in the period between batch release and the purchase from the company located outside the EEA.

A wholesaler may only purchase medicines from other authorized wholesalers within the European Union (EU).If a wholesaler wants to purchase medicinal products  from manufacturers or wholesalers outside of the EU, an import license is required according to art. 12 bis of the medicines law of 25 March 1964.

This clear communication will end constructions with invoices passing by Switzerland for fiscal optimization.

More information can be here.

Adapted guidelines on labeling and packaging of human medicines

February 12, 2018


The guidelines on labeling of medicines have been adapted. With these adaptations, the guidelines are more in line with the European and other national and international guidelines.

Main changes are:

  • Information in braille: the strength and/or pharmaceutical form only have to be added on the packaging of medicines if different strengths and/or pharmaceutical forms of this medicine exist. In case the strength is in micrograms, it is sufficient to mention ‘mcg’ in braille.
  • Unique identifiers (2D matrix code and human readable information) have to be added according to the QRD-template.
  • The definition of small packages has been expanded.
  • The definition and submission of mock-ups have been added.
  • Information on the use of trade marks, symbols ® and TM, or ‘brand of’: these marks are not accepted due to their promotional nature and as they are not useful for the patient. However, there have been some exceptions.
  • Information on the use of logos and QR codes.
  • Additional section on the labeling of combination packages and labeling of homeopathic medicines.

The complete guideline on labeling of medicines can be consulted here.