The European Union (EU) is an economic and political union of 27 member countries. With the constantly shifting markets and government regulations in the EU healthcare regulatory environment, coupled with the UK BREXIT situation, these have created a high degree of uncertainty and complexity for healthcare companies who intend to conduct business in EU and UK. Other challenges include the diverse regulatory regimes in European countries in the areas of:
(including Biologics and Orphan drugs as well as Herbal & Traditional Herbal Medicines)
The rules governing medicinal products in European Union include regulations, directives and guidelines related to procedural and regulatory requirements. The European Medicines Agency (EMA) and the competent authorities of the European Member States are responsible for the scientific evaluation of applications for medicinal products (human and veterinary), biologics and orphans.
With Brexit, the UK is no longer an EU member state and, after a transition period that began on 1 February 2020 and is due to end on 31 December 2020, UK will be considered a third country. The European pharmaceutical law will no longer apply to UK. Consequently, after the transition period any regulatory activity related to medicinal products for the UK market will be handled nationally by the UK Medicines and Healthcare products Regulatory Agency (MHRA), separately from European procedures.
Pharmaceutical companies planning to have medicinal products on the UK market after the transition period must be prepared for the Brexit scenario. This situation has legal impact on the legal basis and registration procedures of new Marketing Authorization applications, manufacturing (including testing and release to the market) and importation of finished products and APIs, pharmacovigilance responsibilities, orphan designations, paediatric plans and inspections.
For Traditional Herbal Medicines, the evidence that the product is used with the indication for a specific period of time is the basis for a marketing authorisation application. Mainly national applications are submitted for traditional herbal medicines.
Herbal Medicinal Products have to follow the same requirements as medicinal products with a small molecule API, but in addition also the provisions of Good Agricultural & Collection Practices (GACP).
Medical Devices / In-Vitro Diagnostics: preparing for new EU regulations
The new EU Regulation on medical devices (MDR 2017/745), delayed until May 2021 due to COVID19, and the EU Regulation on in-vitro diagnostics (IVDR 2017/746), the implementation date of which remains as May 26th 2022, are challenging for all involved stakeholders. Whether authorities, notified bodies, manufacturers, distributors, importers and other subcontractors/suppliers involved – the new regulations and their increased requirements are burdensome and will be a major game changer.
The European Commission published some high level transition guidances for medical device and IVD companies which are a good basis to plan a stepwise preparation. But everybody moving into deeper details will realize it as a Herculean task demanding both a solid strategy as well as respective resources.
Needless to say that a custom-fit transition strategy is the key. MDR/IVDR transition services include:
Although the rules governing food products, especially food supplements, in the European Union are based on EU regulations, directives and guidelines, national procedures have to be followed in some EU Member States to notify food supplements. Limits for vitamins, minerals and other substances with nutritional or physiological effects are in place in some EU Member States, as well as country specific warnings.
Cosmetic products are regulated by the EU cosmetic regulation and the EU regulation on claims for cosmetic products. They have to be notified at an EU portal before placing them on the EU market. Nevertheless, particular labelling information have to be provided in the languages of the countries in which the product is marketed. Also there might be different views in the EU Member States regarding what is acceptable as a cosmetic claim or what could be considered misleading information to consumers.
Montrose R+ Pte Ltd, working with our sister companies Dr. Regenold GmbH, CE plus GmbH and our international regulatory affairs network regulanet® , is your one-stop station offering professional services and assistance to register products in both the EU and the UK.