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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.

When does the Sunshine Act come into force?

April 14, 2017

FAMHP

On December 27th 2016, the Sunshine Act was adopted in Belgium. It introduces a new transparency obligation applicable to the pharmaceutical and medical devices industries. The legislation requires pharmaceutical manufacturers, importers and distributors, as well as retailers and medical device manufacturers, to disclose all pecuniary advantages or benefits provided to healthcare professionals, healthcare organisations and patient associations registered in Belgium. According to this law, any transfer of value in money or in kind must be notified to the FAMHP.

For this law to be effective, two Royal Decrees on the disclosure obligation are in preparation. The first Decree concerns the types of transfers of value and the practical and technical arrangements. In the second Decree, an organization -anticipated to be Mdeon- will be assigned responsibility to perform the functions and tasks on behalf of the FAMHP. After publication of these Decrees, the Sunshine Act can enter into force. This is expected for April 2017.

The obligation to disclose will however apply to all transfers of value provided from January 1st 2017 to December 31st 2017. Related notification of these transfers of value is due likely by May 31st 2018 at the latest. A record of all transfers of value must be kept by companies for a period of 10 years from the date of publication.

Medicine Shortages and Defects Notification Centre

April 14, 2017

FMEB and IGZ

On January 2nd 2017, the Medicine shortages and defects notification centre went live. The centre is coordinated by the Medicines Evaluation Board (MEB) and the Health Care Inspectorate (IGZ).
Via one central point, marketing authorisation holders and manufacturers can submit the following notifications:

  • A medicinal product is placed on the market for the first time, or again following an interruption
  • The marketing of a medicinal product is being discontinued or interrupted
  • A possible shortage because a medicinal product is being placed on the market in smaller quantities
  • A quality defect in relation to a medicinal product

Please keep in mind that as stipulated in Article 49 of the Dutch Medicines Act marketing authorisation holders and manufacturers are obliged to report the availability on the market and (possible) shortages of a medicinal product.

Relocation of European Medicines Agency

April 14, 2017

The European Medicines Agency (EMA) is currently located in Canary Warf in London. Following the triggering of Article 50, the process will commence to decide on its relocation. The Agency works with individual regulatory authorities from all 31 European Economic Area member nations. Assuming it moves out of London when Brexit is complete, it would mean shifting 890 jobs currently located in Canary Wharf in East London. The decision on the seat of the agency will not be taken by EMA, but will be decided by common agreement among the representatives of the member states. This might be a hard nut to crack!

Sweden believes it is the “most serious contender” among a half-dozen nations to be the new home of the EMA. But although the Swedes are confident of luring the EMA, they face stiff competition in a bidding war also involving the Irish Republic, Spain, Denmark, Germany and Italy. In our region, both Belgium and the Netherlands have applied as official candidate. And who knows, in case of dispute, Brussels might be the classic EU compromise.

New Royal Decree on herbals

March 21, 2017

On January 24th 2017, the new Royal Decree on the manufacture and distribution of food supplements containing herbs or herbal preparations was published, adapting the RD of August 29th 1997. The main change concerns the addition of many botanicals from the BELFRIT list: the harmonized list of admissible plants in food supplements, as jointly defined by BELgium, FRance and ITaly.

In the new Royal Decree, the number of authorized plants has been increased from 645 to over 1.000. Additionally, maximum levels and mandatory warnings have been added for several herbals. This should help encouraging and facilitating the free movement of supplements based on herbal ingredients in the EU, also ensuring at the same time a higher level of protection for consumer safety.

The Royal Decree factored in a transition period, allowing food supplements that do not comply to sell through up to two years after the decree came into force.

Nasal corticosteroids: switch to OTC

March 7, 2017

As a result of prolonged use and overuse of nasal decongestants, the Belgian Health Authorities have decided to switch intranasal corticosteroids to OTC-status. OTC-use is recommended especially for intranasal corticosteroids with low systemic absorption e.g. mometasone and fluticasone. These days, a good opportunity for the public pharmacists to stress their advising role and point out to patients that, unlike the nasal vasoconstrictors, there will be no immediate relieve when using intranasal corticosteroids.

QA and RA Consultant

December 9, 2016

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

Regulatory Affairs Associate

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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.

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November 18, 2016

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