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Ban on inducements in the Dutch medical device industry

September 20, 2017

CGR

Earlier this year, the Medical Devices Act in the Netherlands has been adapted thereby introducing a ban on inducements that are aimed at stimulating the prescription or supply of medical devices. Details on this policy have been published by the Dutch Foundation for the Code for Pharmaceutical Advertising (CGR) and can be found in their newsletter.
Similar to the Medicines Act, inducements for medical devices are also forbidden, except for following exemptions:

  • Sponsoring is permitted when it complies with certain conditions.
  • Contributions to costs related to meetings and events is allowed. However, understanding of the words ‘meetings’ and ‘events’ in case of medical devices is slightly different from those described in the law on medicines.
  • Fee for services can be granted similarly as in the scope of medicines.
  • Gifts are permitted with a maximum of €50 per gift and €150 per year per supplier (but not per therapeutic classification).
  • Reductions and bonuses can be offered. Additional conditions are included in the policy.

The Medical Devices Act and this policy enter into force on 1 January 2018. The Dutch Ministry of Public Health (VWS) has announced its intention to adapt the policy for medicinal products as well, which will likely be adapted and aligned with the policy for medical devices. Which implicates that also for the specific conditions for sponsoring are to be expected.

Improvement of EMA’s guidance on post-authorization activities

September 13, 2017

EMA

The best practice guidelines and support documents for marketing authorization holders (MAHs) have been updated by EMA. The amendments involve topics concerning type II variations, post-authorization safety studies (PASS) and changes related to quality aspects.
The most important updates are:

  • A new pre-submission checklist for type II variation applications. This validation checklist will help applicants to submit complete and correct type II variation packages.
  • An updated Q&A for PASS with 15 new questions and answers. This Q&A includes detailed information on submission requirements, assessment and implementation of outcomes for protocols, protocol amendments and final study reports of non-interventional imposed PASS.

An update of the ‘Classification of post-authorization changes – Quality aspects’. Eight new Q&As to advise MAHs on post-authorization procedures, including additional variation classification categories.

Guidelines on the Falsified Medicines Directive

September 12, 2017

FAMHP

Recently, FAMHP has published guidelines as well as Q&A documents related to the Falsified Medicines Directive.

No later than 9 February 2019, safety features as imposed by the Falsified Medicines Directive 2011/62/EU of the European Parliament and of the Council should be placed on the packaging of most medicinal products for human use. Safety features include a unique identifier (a 2-dimension barcode) and an anti-tampering device.

These guidelines are not applicable to medicinal products that are included in Research & Development trials and did not yet obtain marketing authorization. They do also not apply to veterinarian medicines.

By implementing these safety features, falsified medicines can be prevented from entering the legal supply chain. In this way, medicine authenticity should be guaranteed for patients, manufacturers, distributors, pharmacies and hospitals.

EMA’s relocation is delayed

September 11, 2017

EU

The relocation of the European Medicines Agency (EMA) due to Brexit will take longer than expected. Nineteen countries offered to host EMA and especially the Netherlands are very interested to become EMA’s new home base. One of the reasons for this is the creation of many jobs resulting in several economic benefits.

The host country has to fulfill 6 criteria to be an appropriate candidate. The most important criterium is the ability for EMA to be functional immediately following Brexit. Also important are accessibility, international schools, jobs and care for partners and children, operational continuity and geographical distribution. By the end of September, EMA will publicly share its evaluation. The voting will take place in November and the final decision will be announced 20 November 2017.

Also Belgium has applied, so that the best may win!

Switch from paper to electronic format: eCTD

September 6, 2017

EU

As from the third quarter of 2018, also purely national marketing authorization applications have to be submitted in eCTD format. For follow-up procedures (e.g.  variations, renewal applications) of these national procedures, the switch to electronic format will be adopted from the first quarter of 2019 onwards. Marketing authorization holders of purely national marketing authorizations, therefore, should switch their files to eCTD no later than by the end of 2018. According to eSubmission roadmap version 1.0, the eCTD obligation for decentralized or mutual recognition procedure will already be effective from 2018 onwards.

More information on this topic can be found here.

New and improved version of Eudravigilance

September 4, 2017

EMA

On 22 November 2017, a new and improved version of EudraVigilance will be launched by the European Medicines Agency (EMA).
Users of this system, including marketing authorization holders and sponsors of clinical trials, should prepare themselves to ensure that their procedures and local IT-infrastructures are compatible with the new system as well as with the internationally approved format. This improved version will be launched simultaneously with the implementation of the new legal obligations of reporting electronically via EudraVigilance, as announced by the EMA Management Board.

More information can be found at EMA’s website.

Mdeon’s recognition as transparency platform

August 31, 2017

On 22 August 2017, the Royal Decree of 31 July 2017 was published in the Belgian Official Journal. This Royal Decree confirms the recognition of the non-profit-making association Mdeon to perform the transparency tasks that were entrusted to the FAMHP. Mdeon is now officially authorized to manage the transparency platform betransparent.be as described in the Sunshine Act, and is thus responsible for the management of the annual disclosures of premiums and benefits that were granted from pharmaceutical and medical devices companies directly or indirectly to healthcare professionals, healthcare organizations or patient associations.

Mdeon’s recognition has been granted for an indefinite period.

IN2Pharma’s 10th Anniversary!

June 28, 2017

On June 15th, we celebrated IN2Pharma’s 10th anniversary and opening of the new offices, together with many clients and business contacts.
Take a look at our Facebook page for an impression of the unique atmosphere that day!                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                      .

Implementation of the Sunshine Act: the Royal Decree is published!

June 23, 2017

Hot news: The Royal Decree (RD) that implements the Sunshine Act is published today, June 23rd 2017! We summarize the most important changes compared to the current practice on betransparent.be, which was solely based on the Deontological Codes of the industry associations as there was no legal basis yet.

As from now, besides Rx medicines and medical devices, also over-the-counter (OTC) medicinal products are in scope and will need to retro-actively comply with this RD for all transfers of value made since January 1st 2017. In addition, as the definition of a healthcare professional (HCP) in this RD has slightly changed, with the inclusion of veterinarians, the Sunshine Act is applicable to the business of veterinary medicines as well. However, animal health companies get an exemption from this obligation for one year and will only disclose as from 2018.

Furthermore, transfers of value made by a pharmaceutical company for the benefit of a HCP must be disclosed in name of the HCP, even if the HCP acts from a legal entity (NV/SA or bvba/sprl).

Indirect transfers of value (through a third party, congress organizer or a hospital) have to be disclosed in name of the final beneficiary HCP. This is no change, but in practice, this was hard to comply with for many pharmaceutical companies. This responsibility is now being shifted to the third party who will need to inform the pharmaceutical or medical device company of the identity of the final beneficiary and the exact amount he/she received. This information must be provided to the company at the latest on December 31st of the reference year.

As you know, transfers of value to patient organizations were to be made publicly available on the company’s website. According to this RD, however, these transfers of value need to be included in the transparency report.

Transfers of value must be disclosed in the year of the financial transaction, even if this year differs from the year that the services were provided.

And last but not least, an extra month was added to finalize the transparency report! Disclosure has to be made available at the latest on the 31st of May of the year following the financial transaction.

In conclusion, this RD clarifies several grey zones in transparency but also transforms a deontological commitment into a strict legal obligation!

What to do: Post-Brexit

June 22, 2017

EU

To prepare the UK’s withdrawal from the EU, EMA and the European Commission published the first in a series of Q&As for pharmaceutical companies on May 31st 2017. This guidance applies to pharmaceutical companies of both human and veterinary medicines and contains information on the location of establishment of a company in the context of centralized procedures and certain activities, including the location of orphan designation holders, qualified persons for pharmacovigilance (QPPVs) and companies’ manufacturing and batch release sites.

A series of further guidance documents on the consequences of Brexit will be published here.