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Policy Rules Inducement Medicines Act 2018

February 27, 2018

The Netherlands

The Policy Rules on Inducement in the Dutch Medicines Act have been adapted and will go into effect on 1 April 2018. The main reasons for the adaptations were 1) unclarity on the limits of hourly rates for services to medical specialists, and 2) differences in some topics as compared to the Policy Rules Inducement Medical Devices Act which has become effective on 1 January 2018.

Among others, the definitions of healthcare professional and entrepreneur, the conditions for sponsoring, the maximum value of gifts, and hospitality if provided through a third party have been supplemented and/or adapted.

More details 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.

Revised policy on compliance practices across the global medical technology industry

February 12, 2018


Medical technology companies around the world strengthen their policy on the support of third-party educational events. The ethical codes of China (the AdvaMed China Code), Europe (the MedTech Europe Code), the Middle East and North Africa (the Mecomed Code), and the Asia-Pacific region (the APACMed Code) have been revised to strengthen the collective commitment to training & education of healthcare professionals (HCP) and to ethics & integrity.

One of the main adaptations in these codes is that “direct sponsorship” of HCP attendance at medical conferences and congresses, including registration fee, travel, lodging and hospitality, has been eliminated, effective 1 January 2018.

They, however, emphasize that these revisions are not to diminish companies’ commitment to HCP training & education as it remains critical for the continued development of advanced medical technologies, as well as for their safe and effective use for the benefit of patients. This revision was rather to adapt the way that third-party educational events can be supported.

More details on the revisions can be found here.

Autocontrol and ‘only once-principle’

February 6, 2018


The Royal Decree of 15 November 2017 regarding the notification of a materiovigilance contact point and the registration of distributors and manufacturers of medical devices concerns the introduction of a new registration procedure that should limit the administrative burden following the ‘only once-principle’. So, the aim is to collect all information that is already known within the authorities (KBO/BCE, VAT databank).

Practical consequences?

  • ABGD/SADN application will be replaced by a new web portal
  • Manufacturers and importers will no longer be encoded by the system as ‘distributor’ but instead according to their exact activity

Additionally, new rules are laid down in this Royal Decree concerning market surveillance of medical devices.

Amendment of the policy on labeling of human medicines

February 5, 2018

The Netherlands

The policy on labeling of medicinal products for human use (MEB 6) has been amended by the Medicines Evaluation Board (MEB). As a consequence, the policy on the summary of product characteristics (MEB 27) and the package leaflet (MEB 5) have been updated as well.

The most important changes are the following:

  • The ‘Marketing Authorizations without Dutch translations of the product information or mock-ups’ has been aligned with the policy document MEB 41 on ‘College policy on marketing authorizations without Dutch translations of the product information and/or mock-ups’.
  • In the section on ‘Images/Representations of the indication’, it has been added that the abbreviated indication is subordinate to the listing of the product name on the packaging.
  • New section on safety features:
    • Information has been added concerning the listing of safety features on the packaging in accordance with the European Falsified Medicines Directive.
    • Information has been added regarding unique identifiers
  • A topic concerning the combination of multiple codes (QR-code and 2D-barcode) on the packaging has been implemented. This has been adapted in Annex 3 as well.
  • With regard to childproof packaging/senior-citizen friendly packaging, a section on the translation into Dutch of claims concerning child safety present on the packaging and the product information has been added.

More information and policy documents can be consulted at the CBG website.

Union list on novel foods

February 5, 2018


The Union list on novel foods has been published in The Official Journal of the European Union on 20 December 2017. On 1 January 2018, this novel food regulation has come into effect.

This novel food regulation introduces a centralized authorization procedure for novel foods. All applications will be submitted directly to the EU Commission instead of to individual Member States and the European Food and Safety Authority (EFSA) will conduct a scientific risk assessment if needed. Application can be done via two different procedures:

  • The authorization procedure for novel foods
  • The notification procedure for a traditional food from a third country

All approved novel foods will be transformed into a generic authorization with this Union list. In addition, novel food approvals will no longer be holder-specific. All Food Business Operators complying with the conditions and specifications laid down in the Union list will be able to market a novel food which is identical to one that has already been approved, without having to apply for a substantial equivalence.

Additional legislation can be found here:

  • Commission Implementing Regulation (EU) 2017/2468 of 20 December 2017 laying down administrative and scientific requirements concerning traditional foods from third countries in accordance with Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods;
  • Commission Implementing Regulation (EU) 2017/2469 of 20 December 2017 laying down administrative and scientific requirements for applications referred to in Article 10 of Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods;
  • Commission Implementing Regulation (EU) 2017/2470 of 20 December 2017 establishing the Union list of novel foods in accordance with Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods.

eCTD mandatory for MRP and DCP

February 5, 2018


As from 1 January 2018, it is obliged to submit the common technical document (CTD) electronically for variations of human medicines, registered via the Mutual Recognition Procedure (MRP) or Decentralised procedure (DCP).

This eCTD format is mandatory for the submission of new marketing authorization applications as well as for submissions regarding on-going regulatory activities, such as follow-up submissions for variations, periodic safety update reports, notifications, responses and renewals. It also includes active substance master file submissions used in European procedures and responses or supplementary information in ongoing MRPs.

More information can be found on the EMA eSubmission website.

Guide on Medical Devices Regulations

February 5, 2018

The Netherlands

The European Regulation for medical devices (MDR) and in vitro diagnostic medical devices (IVDR) will fully apply in 2020 and 2022, respectively. This new regulation will have consequences for the marketing authorization of medical devices.

The ministry of Health, Welfare and Sport (VWS) together with the Inspection and the Dutch National Institute for Public Health and the Environment (RIVM) developed a guide to help all parties prepare for 2020 and 2022. This guide includes the most important changes that come together with these new regulations and can be consulted here.

EMA moves to Amsterdam

January 24, 2018


Finally, it is decided! The European medicines Agency (EMA) will relocate to Amsterdam following UK’s withdrawal from the European Union. The decision followed an assessment of the bids by the European Commission and EMA. By 30 March 2019 at the latest, EMA should be in operation in Amsterdam.

EMA’s relocation will also impact the continuous supply of medicines for human and veterinary use within the European Union. Marketing authorisation holders, applicants and sponsors of centrally authorised medicines should consider which changes have to be addressed before the United Kingdom leaves the European Union. Necessary changes should be made by 30 March 2019 at the latest. To help pharmaceutical companies prepare for Brexit, EMA has published a procedural guidance and a Questions & Answers document.