Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.
MHRA Drops Statement That Avoiding No-Deal Brexit is the ‘Top Priority’
The United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA) has indicated a shift in the government’s willingness to countenance a no-deal Brexit in an update to its guidance on exiting the EU.
No-deal Brexit guidances published by MHRA and other parts of the UK government while Theresa May was Prime Minister typically started with the following statement: “Leaving the EU with a deal remains the government’s top priority. This has not changed. However, a responsible government must plan for every eventuality, including a no-deal scenario.”
Today, May is out of office, replaced by someone who has publicly expressed a far-greater willingness to take the UK out of the EU without a deal. The new Prime Minister, Boris Johnson, has publicly adopted the position that the UK will leave the EU on 31 October with or without a deal, “do or die, come what may.”
The statement about leaving the EU with a deal being a top priority was the first line of the guidance on converting Parallel Distribution Notices (PDNs) to UK Parallel Import Licenses (PILs) that MHRA published in March, as well as guidances on pharmacovigilance, clinical trials, pediatric studies, new assessment routes, regulating medical devices, licensing of biological products, decentralized and mutual recognition procedures and approved countries for batch testing and importation of medicines in a no-deal scenario. This week, MHRA posted the nine revised guidances. A notable change to the information in each guidance is the removal of the statement about the UK leaving with a deal being the government's “top priority.”
Other changes include the removal of a statement about legislation converting PDNs into PILs on the day the UK leaves the EU. MHRA has also cut a week from window companies will have to opt in to the PDN to PIL conversion process. Under the new guidance, MHRA is giving companies three weeks after the UK leaves the EU to submit a list of the valid PDNs that need converting. Companies that fail to submit the list on time will need to file a new application for a parallel import license.
MHRA published the revised guidances against the backdrop of a shift in the tone the UK government is taking when discussing Brexit. Under the leadership of Johnson, who, unlike his predecessor, campaigned to leave the EU before the referendum vote, the government has talked up the prospect of leaving without a deal and taken actions designed to prepare the UK for that eventuality. Those actions include the provision of an additional £434 million ($527 million) to “help ensure continuity of vital medicines and medical products, including through freight capacity, warehousing and stockpiling," health minister Chris Skidmore said in parliament last month. “We are confident that the department is doing everything appropriate to prepare for a possible no deal EU exit on 31 October. We are working with our partners, including suppliers, freight companies and the health and social care system and our plans should ensure the supply of medicines and medical products remains uninterrupted."
That impression of a coordinated response was undermined by UK trade group the BioIndustry Association (BIA), which told the government “we now need the detail of how the money will be spent.” BIA’s 1 August statement noted that the need to ship medicines under regulated, controlled conditions means supply routes need to be known in advance of exit day, adding that its members have invested to prepare for Brexit “with little government support.”
EMA Gives Makers of Liposomal Drugs Until October to Change Product Names
Guidance, Skidmore Statement, BIA Statement
The European Medicines Agency (EMA) has given manufacturers of liposomal medicines until the end of September to change the names of their products. EMA made the request to mitigate fears that confusion between liposomal and non-liposomal medicines could cause medication errors.
Liposomal and non-liposomal formulations of the same active ingredient may have distinct release and biodistribution properties that could result in negative health outcomes if a patient used them interchangeably. There is evidence that has happened, leading to the deaths of some patients. EMA responded to the deaths by designing a strategy to cut the risk of mix ups between medicines.
The agency wants manufacturers to modify section one of the summary of product characteristics (SmPC) so that the qualifier “liposomal” or “pegylated liposomal” features after the invented name and before the strength.
If the drug is approved with an “international non-proprietary name (INN)+company or trademark” name, the manufacturer must add the appropriate qualifier between the INN and the company name or trademark in section one of the SmPC. EMA also wants companies to use the standard term “dispersion,” the definition of which covers liposomes, consistently in product information.
Manufacturers affected by the change need to submit an A.2.a variation. EMA expects companies to file the request by the end of September.
MHRA to Make Allergy Test Available Over The Counter Despite Opposition
MHRA is making a hair dye allergy test available over the counter (OTC) despite opposition to the idea. Three out of five professional bodies objected to making a test for paraphenylenediamine (PPD) allergy available without a prescription but MHRA is forging ahead with the change.
When MHRA asked whether the Colourstart Test Patch should be made available OTC last year, the National Pharmacy Association (NPA), British Society of Cutaneous Allergy and British Association of Dermatologists all objected to the proposal. NPA objected on the grounds that continuing to provide the patch through pharmacists would enable consumers to get advice on interactions with medicines and other complicating factors.
The allergy and dermatology groups jointly delivered a more comprehensive breakdown of why they think it is a bad idea to make the test available without a prescription, including an analysis of the perceived safety risks.
“In cases of suspected severe allergy to PPD a dermatologist performing patch tests will likely vary the test concentration of PPD ... so as to prevent an unnecessarily severe patch test reaction. Some patients could therefore expect to develop severe localized bullous reactions to this equivalent ‘diagnostic patch test’ material. This could result in scarring or long lasting or permanent hypopigmentation or hyperpigmentation,” the professional bodies wrote to MHRA.
Despite those concerns, MHRA is ending the need to have a prescription to access the test. MHRA framed the change as providing greater convenience and choice for consumers.
, Consultation Outcome
Spain Takes Action Against Distributor of Active Pharmaceutical Ingredients
The Spanish Agency of Medicines and Medical Devices (AEMPS) has issued a notice about active pharmaceutical ingredients (APIs) distributed by Vencaser. AEMPS wants the company to stop distributing APIs due to concerns they pose a risk to public health.
AEMPS reached that position after inspecting the company. The inspection raised concerns about the quality system, competence of technical staff, adequacy of storage facilities and other elements required of an API distributor, leading AEMPS to conclude Vencaser is noncompliant with EU rules.
The AEMPS action against Vencaser will remain in place until the company is verified to be compliant with the rules. Vencaser distributed APIs including omeprazole, orlistat and lidocaine for use in the manufacture of medicines.
’s Health Products Regulatory Authority
(HPRA) is recruiting a good manufacturing practice (GMP) inspector. The GMP inspector will evaluate the compliance of sites in Ireland and overseas with manufacturing regulations. HPRA Advert