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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 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, 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


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.

eSubmission of Medicines

June 21, 2017


As from June 1st 2017, submission of regulatory information by applicants for marketing authorizations regarding human medicines must be submitted electronically (eSubmissions) to the Medicines Evaluation Board (MEB). All submissions have to be technically valid and must comply with the required format.

eSubmissions must meet the eCTD (electronic Common Technical Document) standard or the NeeS (Non eCTD electronic submission) specifications. Technical validation will be performed by MEB conform the common European criteria as published on the European eSubmission website.

Registration for Marketing Authorization Holders

June 21, 2017


Every Marketing Authorization Holder (MAH) that distributes medicinal products that fall within the Belgian scope of the Falsified Medicines Directive (FMD) by February 9th 2019 must register to and contract with the Belgian Medicines Verification Organisation (BeMVO). In addition, they must contribute in the overall costs of the system via the one-off registration fee and the yearly flat fee.

The scope of the FMD legislation is defined by the Belgian authorities as follows:
– All products that are subject to a prescription according to the Belgian legislation
– Plus the black list products as identified in annex 2 of the FMD
– Minus the white list products as identified in annex 1 of the FMD
– Plus all reimbursed products bearing a RIZIV/INAMI reimbursement serial barcode today; except if listed on the white list.

More details can be found in the scope decision table.

The different steps to be compliant and more information on how to use the Belgian Medicines Verification System can be found here.

Increased transparency

June 20, 2017


In the Netherlands, 58.2 million euros have been reported to the Healthcare Transparency Register for 2016 which is a 13% increase in comparison with last year. For the fifth year in a row, transparency between pharmaceutical industry, healthcare professionals, healthcare organizations and patient organizations is increased.

One of the reasons for this increase is the expansion of the Register to distributors of medical devices (ca. 2 million euros). The additional increase is due to the incremental cooperation between healthcare organizations as well as the cooperation between healthcare professionals and pharmaceutical companies.

Collaborations between parties have to be disclosed along with the payments that are associated with it to the Healthcare Transparency Register. The purpose of the Register is to make relationships between healthcare professionals and healthcare organizations more transparent. Moreover, it is publicly available on the internet.

Revision of guidelines of veterinary medicines for MUMS

May 10, 2017


The Committee for Medicinal Products for Veterinary Use (CVMP) has updated the current guidelines on veterinary medicines for minor uses and minor species (MUMS). These revised guidelines provide more clarity on data requirements and include three guidelines explaining which data are required to demonstrate quality, safety and efficacy. The fourth revision concerns specific considerations for immunological veterinary medicines for MUMS. The guidelines point out in which cases data requirements can be reduced. Furthermore, they facilitate the determination of studies that are required for obtaining marketing authorization. This should stimulate the development of veterinary medicines and immunological products for MUMS, eventually leading to an improvement of animal health care.

More information can be found here.

MEB 48: a national informed consent marketing authorization application

May 9, 2017


The Medicines Evaluation Board (MEB) introduced MEB 48, a new policy concerning the application of marketing authorizations for medicines that are identical to medicines already authorized. For this, a national informed consent marketing authorization application has to be used including a copy of the full dossier of the reference medicine. However, when applying for a license to market such a medicine, the company needs to have permission of the marketing authorization holder of the reference medicine. If the reference medicine is authorized for less than 5 years, the application procedure will take 45 days at maximum. If the reference medicine is authorized for more than 5 years, the application procedure can last up to 210 days.
Summarized, MEB 48 thus promotes the authorization of generic medicines!

Electronic submission of advertising to the public

April 19, 2017


As described in a new Circular Letter (circular 634), FAMHP now accepts electronic submissions of advertising notifications and visum applications (for TV or radio spots) as well as information campaigns.

Although it is not a requirement, FAMHP strongly recommends to submit files for public advertisings via email to the new email address
Three application forms are provided depending on the kind of publicity:

As the Royal Decree of April 7th 1995 remains into force and specifies that applications have to be sent to FAMPH by registered mail, the completed and signed application forms must still be sent to FAMHP by registered mail. But as this can be done after approval has been obtained, this electronic submission will save time and is a through simplification!