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eSubmission of Medicines

June 21, 2017

MEB

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

BeMVO

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

CGR

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

EMA

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

MEB

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

FAMHP

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 advertising@fagg.be.
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!

New Medical Device Directive

April 14, 2017

EU

Finally some progress! The final versions of the European Medical Device and In Vitro Diagnostic Regulations (MDR and IVDR, resp.) have finally been approved by the European Parliament on April 5th 2017. Formal publication of the MDR and IVDR in the Official Journal of the European Union is anticipated for early May 2017. Twenty days from that publication, likely in early June 2017, the Regulations will enter into force. Accordingly, the MDR will probably be applicable by 2020 and the IVDR by 2022.

Update of MRA between EU and US

April 14, 2017

EU

The European Commission and the United States Food and Drug Administration (FDA) have updated the EU-US 1998 Mutual Recognition Agreement (MRA). According to this amendment, the EU and US regulatory authorities now mutually recognize inspections of pharmaceutical manufacturing facilities.

The aim of this MRA is to avoid the duplication of inspections, to lower inspection costs and to enable regulators to devote more resources to other parts of the world where there may be greater risk.

The MRA states that by November 2017, FDA must have assessed authorities in eight EU countries and that FDA’s assessment of all of the EU national agencies has to be completed by July 15th 2019.

Food (supplements) and health claims

April 14, 2017

EU

Recently, based on a German case, the Court of Justice of the European Union decided to restrict the EU Health Claims Regulation (Regulation (EC) No 1924/2006 on nutrition and health claims made on foods). In this case, food supplements were promoted towards health care professionals exclusively using nutrition and health claims. This resulted in the question whether or not nutrition and health claims, made in commercial communications towards health care professionals solely, fall within the scope of the EU Health Claims Regulation. The Court decided that whereas in some EU Member States only health-related advertising towards the general public had been restricted under the previous regulations, under the EU Health Claims Regulation the same restrictions apply for advertising both inside and outside of the professional sector.

Health care professionals are considered to act as information intermediaries who issue recommendations concerning certain food supplements to consumers. Any information provided to health care professionals may affect consumers as well. Consequently, with these restrictions, a higher level of consumer protection can be guaranteed but at the other hand, promotion of food supplements towards health care professionals becomes much more restricted !

Pyrrolizidine alkaloids in herbal medicines

April 14, 2017

FAMHP

The Committee on Herbal Medicinal Products (HMPC) published new recommendations for risk management and quality control of herbal medicinal products (HMPs) and traditional HMPs. The additional control measures issue the contamination of HMPs with toxic pyrrolizidine alkaloids (PAs) which can cause liver hemangiosarcoma in humans. The view of HMPC is that patient exposure to PAs from HMPs should be as low as possible and should not exceed a daily intake of 0.35 μg. However, for a limited transitional period an intake up to 1.0 μg per day can be accepted.

Contamination of herbal products (food and medicines) cannot be a new phenomenon, but today new, sensitive analytical methods can detect very low levels of PAs in foods and medicines . As a result, Marketing Authorization Holders (MAHs) are advised to implement suitable testing procedures to ensure PA levels are controlled in line with limits agreed. Also measures to avoid or reduce PA contamination in HMPs are recommended to be implemented.

Based on these recommendations, an analytical variation type II with the results of a risk analysis, a risk management plan and the implementation of routine testing of toxic PAs should be submitted to FAMHP if the (traditional) HMPs contain at least 1 of the specified herbal ingredients or derived preparations at highest risk of contamination. MAHs of other (traditional) HMPs should keep a risk analysis and risk management plan available to FAMHP.

More information on these recommendations can be found here.