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Revised policy on compliance practices across the global medical technology industry

February 12, 2018

International

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

Belgium

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

EU

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

EU

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

EMA

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.

Call for verification of delivery status

January 24, 2018

FAMHP

The Federal Agency for Medicines and Health Products (FAMHP) calls on Marketing Authorization Holders (MAHs) to verify the delivery status of their medicinal products.

Prescription medicinal products are classified into following categories:

  • medicinal products on medical prescription for non-renewable delivery;
  • medicinal products on medical prescription for renewable delivery (oral contraceptives);
  • medicinal products subject to special medical prescription (psychotropic substances and narcotics);
  • medicinal products subject to “restricted” medical prescription, for example, those reserved for treatments that may only be followed in hospital environments or due to the fact that the diagnosis of the disease for which they are being used must be made in a hospital environment or because a prescription drawn up by a specialist is required.

The “restricted” medical prescription medicines are further classified into subcategories as established by the concerned industry, pharmacist associations, hospital pharmacists, nursing staff representatives, the INAMI-RIZIV, academics, and patients’ representatives. These subcategories are as follows:

  • medicinal products intended for individual medication preparation (IMP);
  • medicinal products for which delivery is reserved for hospital pharmacists;
  • medicinal products for which the first medical prescription must be made by a medical specialist and for which delivery may occur in a retail pharmacy;
  • medicinal products for which the prescription and/or administration are reserved for medical specialists and for which delivery may occur in a retail pharmacy;
  • medicinal products subject to specific legislation.

FAMHP now provides the opportunity for MAHs to verify and, if necessary, comment on the legal status of their medicines prior to publication.

More information can be found on the FAMHP website.

Falsified Medicines Directive in Luxembourg

December 6, 2017

Luxembourg

As from 9 February 2019, the Falsified Medicines Directive (FMD) will apply. Based on this, the Luxembourg National Medicines Verification Organisation (LMVO) will implement a Luxembourg verification system in cooperation with the Belgian National Medicines Verification Organisation (BeMVO).

As stipulated in the FMD and the related Delegated Regulation, the system and its operations must be financed by the MAHs acting within the Luxembourg scope of the FMD.

Therefore, The LMVO requests:

  • A one-off registration fee
  • A yearly flat fee, in line with the recommendations of European National Medicines Verification (EMVO), will be invoiced as from February 2019.

The Luxembourg scope of the FMD is defined as follows:
– All products under prescription according to the Luxembourg legislation
– Plus the ‘black list products’ as identified in annex 2 of the Delegated Regulation
– Minus the ‘white list products’ as identified in annex 1 of the Delegated Regulation
– Plus all products defined by the Luxembourg Competent Authorities.

More details can be found here.

New Royal Decree on nutrients

December 5, 2017

The Royal Decree (RD) of 3 March 1992 on food supplements and ordinary foodstuffs enriched with nutrients has been revised and amended.

In this amendment, the list of vitamins, minerals and oligo-elements has been updated, and new maximum levels of these nutrients have been introduced. These are listed in appendix 1 of the RD. Also, the section on mandatory mentions on the packaging has been extended. If particular amounts of certain nutrients are present in the food supplement (e.g. nicotinic acid, or more than 1000 mg of daily potassium), specific warnings have to be added onto the packaging. In addition, percentages of the reference intake of specific vitamins or minerals as determined in the RD, should be mentioned on the packaging as from now.

Amendments included in the new version of the RD have been published in the Belgian Official Gazette on 31 October 2017 and can be found here.