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Countdown to the launch of the new EudraVigilance system on 22 November 2017: Impact for Belgium and the Netherlands

November 8, 2017

The new EudraVigilance system will become operational on 22 November 2017. In order to implement this new system, the current EudraVigilance system is unavailable as of today (8 November 2017), 1.00 a.m. (Brussels time) until 22 November 2017, 10.00 a.m. (Brussels time), when the new system goes alive. So, we just entered the downtime period. During this downtime period, alternative measures apply for reporting adverse drug reactions (ADRs).

Impact for Belgium and the Netherlands

  • During the downtime period, it is not possible for marketing authorisation holders and sponsors to submit ICSR’s to EudraVigilance.
  • The Belgian agency (FAMHP) will stop sending (serious) ICSRs to the marketing authorisation holders as of 8 November 2017.
  • ICSRs that require submission during the downtime period (these are ICSRs of which the term of 15 days after receipt expires within the downtime period) should be submitted to the new EudraVigilance system within 2 working days from the moment the EudraVigilance system is again operational.
  • Concerning ICSR reporting, there will be no change in languages: Dutch, French and English are acceptable to report ICSRs.
  • Articles from Literature do not need to be resent locally.
  • During the downtime period in Belgium, Emerging Safety issues should be sent to adr@fagg.be. These are reports that may affect the product’s benefit-risk balance. In the Netherlands, there reports have to be sent to the Medicines Evaluation Board (MEB).

More information can be found on the following links:

Join our team!

September 30, 2017

We are growing & looking for an extra colleague!

So if you are looking for a challenging job opportunity, please have a look at the job description attached and send your CV and motivation to jobs@in2pharma.com

Quality Assurance Associate

IN2Pharma is a consulting company passionate about offering solutions in Medical, Regulatory Affairs and Quality Assurance projects for pharmaceutical and healthcare industry. Unlike a staffing company, we don’t deliver staff to our clients, we deliver solutions!  As an IN2Pharma consultant, you mainly operate from our offices at the business centre “Hof ter Loonst” in Kampenhout and work at clients’ sites for 1-2 days per week.

New Swiss legal regime on food supplements expands the market

September 28, 2017

Switzerland and EU

Switzerland has updated its legal regime on food supplements (FS) resulting in a better alignment with the food regulations applicable in the European Union (EU). These new rules facilitate marketing of FS originating from EU member states in Switzerland and vice versa. As a consequence, drastic changes to the products are no longer needed and authorization procedures have become less complicated. In addition, the Swiss orders on food labeling and claims and the use of food additives have been revised. These are now almost fully in agreement with EU regulations.

FS legislation in EU did not reach full harmonization between all member states. For example, each EU member has set its own maximum levels for nutrients and has its own rules on the use of botanical preparations and other substances. As a result, Switzerland also maintained its own maximum levels for vitamins and minerals. These, however, are in line with the EU trend.

One of the major benefits of targeting the Swiss market is the absence of the obligation to register or notify FS. Together with the fact that the new legislation is now more or less in line with EU regulations, it makes commercialization in Switzerland very attractive as it is not accompanied by additional notification burdens or costs. However, verification of compliance of a FS’s composition and labeling remains necessary when introducing the FS onto the Swiss versus EU market.

More information can be found here.

Falsified Medicines Directive: joint declaration

September 27, 2017

Belgium

Riziv/Inami, FAMHP and BeMVO published together a joint declaration concerning the implementation of the Falsified Medicines Directive (FMD) in Belgium. In this joint declaration, several arrangements have been laid down to optimize the cooperation between the above-mentioned health authorities in accordance with the FMD. Among others, the starting date, the FMD score for Belgium, the alignment with Grand Duchy Luxembourg, instructions for package design and submission of variations, and major milestones of the implementation have been included.

Ban on inducements in the Dutch medical device industry

September 20, 2017

CGR

Earlier this year in the Netherlands, the Medical Devices Act 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 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 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.