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Regulatory Focus™ > News Articles > 2020 > 1 > EU Regulatory Roundup: Dutch MEB Hikes Some Medical Device Fees to Cover Rising Costs

EU Regulatory Roundup: Dutch MEB Hikes Some Medical Device Fees to Cover Rising Costs

Posted 09 January 2020 | By Nick Paul Taylor 

EU Regulatory Roundup: Dutch MEB Hikes Some Medical Device Fees to Cover Rising Costs

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.
 
Dutch MEB Hikes Some Medical Device Fees to Cover Rising Costs
 
The Dutch Medicines Evaluation Board (MEB) is hiking up the fees for some medical device services. MEB will now charge €9,000 ($10,000) for consultations on certain medical devices, up from €4.050 under the old fee schedule.
 
MEB took the action after concluding current fees for device consultations are too low. Consultations have been taking longer than expected, rendering the old fee too small to cover MEB’s costs.
 
Other regulatory services were subject to smaller increases. MEB is increasing the fee for procedures by 5%, moving the rate for a new device application up from €13,500 to €14,180. The regulator is also increasing annual fees by 6.5%.
 
MEB pointed to rising costs to justify the increases. Specifically, MEB highlighted increased spending on salaries and housing and the cost of processing reports of drug shortages. Companies that pay annual fees for human medicinal products will cover the extra spending in drug shortages, while the additional housing costs will be spread across all companies that pay MEB fees.
 
The fee increase comes shortly after Ireland’s HPRA proposed ramping up its medical device rates. HPRA’s schedule features a new €5,000 charge for arbitrating between notified bodies and medical device companies, plus increases to existing fees that exceed the across-the-board increment applied to other rates. 
 
MEB Notice
 
Ireland’s HPRA Updates Guidance on Multilingual Packaging
 
Ireland’s Health Products Regulatory Authority (HPRA) has updated its guide to labels and leaflets of human medicines. The new content provides extra information about the use of multilingual text on product labels.
 
HPRA briefly covered multilingual packaging in the version of the guide released late in 2018. The new version significantly expands the section, adding new information on small immediate packaging units, the use of English as a common language and the inclusion of text covering use of the product in the United Kingdom, which will soon be treated as a third country for regulatory purposes.
 
The addition of a section on small immediate packaging units, which HPRA defines as containers of up to 10ml, reflects the unique requirements of these products. Space constraints mean HPRA will permit manufacturers to only include the “minimum particulars” on the label. HPRA is also open to permitting inclusion of just the minimum particulars on containers of up to 50ml, if justified. That flexibility is particularly applicable to packages that feature more than two languages.
 
HPRA has also shown flexibility in other areas. In another new section, HPRA states manufacturers can use English alone to convey “certain particulars in order to save space.” HPRA will accept the use of English in that context “without further justification” but will only allow the use of Latin as a common language “where absolutely necessary.”
 
The timeliest update to the guide covers third countries. With the UK set to leave the European Union and become a third country, HPRA has said “multi-country packs with the UK are acceptable on the condition that the product information is the same” as in Ireland. UK-specific administrative information, such as the UK batch release site, must be placed in the “blue box.”
 
HPRA released the updated guide shortly before Ton de Boer, the chairman of its Dutch counterpart, published an article on the idea that labels should only carry information in English. De Boer rejected the idea, arguing that it is important for drugs sold in the Netherlands to carry information in Dutch.
 
HPRA Guidance, MEB Column (Dutch)
 
Germany to Suspend Some Sartans Until Implementation of Risk-Minimization Steps
 
Germany’s Federal Institute for Drugs and Medical Devices (BfArM) is set to suspend the marketing authorizations of some sartan medicines. BfArM plans to take the action against manufacturers that are yet to implement measures to minimize the risk of nitrosamine contamination.
 
The potential for nitrosamine impurities to cause cancer in patients taking sartan drugs led European authorities to propose risk-minimization measures last year. Shortly before the end of 2019, BfArM identified producers of sartan medicines that are yet to implement the risk-minimization measures and gave them an ultimatum.
 
BfArM wants the manufacturers to take the requested actions and submit documents showing their compliance with the requirements this month. Failure to implement the risk-minimization measures may lead to the suspension of marketing authorizations in Germany.
 
The BfArM notice came shortly after the French National Agency for Medicines and Health Products Safety (ANSM) published a separate request to manufacturers of sartan medicines. ANSM’s request covered the information companies need to submit by 26 March.
 
BfArM Notice, ANSM Statement (French)
 
HPRA Clarifies Role of Batch-Specific Requests for Veterinary Medicines
 
Ireland’s HPRA has revised its guide to batch-specific requests for veterinary medicines. The update, which changes most of the old text, clarifies when batch-specific requests can be used and for what purpose.
 
Manufacturers use batch-specific requests to seek more time to implement an approved variation or agreed changes to labels and leaflets. The requests can assure continued supply of a product, in which case HPRA will typically allow the manufacturer to produce enough batches with the outgoing information or process to supply the market for three months. There is no time limit on requests to correct a quality defect.
 
None of that information was in the old version of the guide. HPRA also used the update to add a section on the requirements placed on companies that attach new information to existing packaging using a rubber band. The attachment of the new information does not need to take place under good manufacturing practice conditions, but should be done by an authorized wholesaler.
 
HPRA Guidance
 
Swissmedic Creates Guidance on Medicinal Product Naming Rules
 
The Swiss Agency for Therapeutic Products (Swissmedic) has released new guidance on the naming of medicinal products. The guidance, which came into force on 1 January, sets out when Swissmedic will reject a proposed name for a human medicinal product.
 
Swissmedic’s interpretation of the law has led it to prohibit the use of names that could harm human health, for example because they could cause one product to be confused for another. That position means companies need to consider whether a proposed name looks or sounds like the name of any existing products.
 
Other restrictions include a ban on promotional language and phrases such as “gluten-free.” Swissmedic will allow companies to use modifiers such as “rapid” and “controlled release,” provided they have data showing the product has the claimed property and that it is clinically relevant.
 
Swissmedic Notice
 
Other News:
 
The Dutch MEB has shortened the timeline for processing changes to parallel package leaflets. MEB will now respond to proposed changes within 30 days. If no response is received in that time, the applicant can make the requested change. Applicants that receive comments from MEB will need to resubmit a request. MEB will take up to 30 days to review the second application. MEB Notice
 
The European Medicines Agency (EMA) has updated a question and answer document about the mutual recognition agreement (MRA) with the United States for marketing authorization applications and variations. EMA has updated the information on how the MRA affects applications and variations. EMA Q&A
 
EMA has updated its guidebook for organizations that submit tenders in response to procurement requests. EMA Guidebook
 

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