Pharma blog: the latest from the industry

On “Pharma Blog”, Diapharm’s corporate blog, members of our staff discuss the current developments and regulatory challenges they face in their areas of expertise. The wide range of topics we cover makes it clear what we are: specialised generalists.

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Post Brexit: Notified bodies in the UK no longer issue CE certificates

For medical devices made by British manufacturers that want to remain marketable in the EU, the last-minute Brexit deal has not brought any relief: As of 31 December 2020, British Notified Bodies are no longer allowed to issue CE certificates. For medical devices of class IIa, IIb and III, however, these certificates are a prerequisite for access to the European market. Conversely, certificates from notified bodies from the EU will soon no longer be recognised in the UK.  more >>
Middeler
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After Brexit: UKCA isolated solution for medical devices

The transitional temporary permissions regime for Brexit will expire before the MDR takes effect on 26 May 2021. This means that the MDR will not automatically be incorporated into existing UK law. Instead, the UK government will adopt a separate law – the Medicines and Medical Devices Bill – which will require all medical devices to be registered in the UK beginning 1 January 2021. The grace periods are short and are based on risk classes.  more >>
Weber
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Medical protective masks – Diapharm lends its support with medical devices

Medical protective masks have become a much sought-after product during the global coronavirus pandemic. These masks are particularly needed in healthcare facilities caring for COVID-19 patients. A distinction is made between medical face masks, which patients wear to prevent them from infecting others, and personal protective equipment (FFP2 and FFP3 masks), which protects the wearer of the mask. Policymakers are forcing the establishment of domestic mask production in Germany, but imports will likely remain necessary in order to continue to meet the already foreseeable demand. However, manufacturers and distributors must keep an important date in mind: From 26 May 2021 at the latest, all medical face masks placed on the market in the EU for the first time must comply with the new Medical Device Regulation (MDR).  more >>
Middeler
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MDR date of application postponed; MDD remains in force

The European Parliament and the European Council have finally agreed to the EU Commission’s proposal to delay the date of application of the MDR by one year until 26 May 2021. The announcement has already been published in the Official Journal. Manufacturers of medical devices now have more planning security again. Products that have been on the market according to the “old” standards of the Medical Device Directive (MDD) and are not yet MDR-compliant are given another chance. In addition, the Medical Device Coordination Group (MDCG) and the EU Commission have a little more time to prepare comprehensive and target-oriented guidelines for the implementation of the MDR.  more >>
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Trend in phytopharmaceuticals: international regulatory extension!

Pharmaceutical companies are increasingly extending the markets for their herbal medicinal products into other EU states, for example using the decentralised procedure (DCP) or mutual recognition procedure (MRP). There is currently particularly high demand for products in the indication areas of women’s health, pain and prevention, and sedation and sleep. No wonder, because the path to new markets is very short – if you are familiar with the regulatory procedures...  more >>
Stromeier
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Quo vadis cannabis?

By now, many companies in Germany have applied to their local regulatory authorities, depending on where they have their registered office, for an import permit or wholesale distribution authorisation. Some are currently preparing to file the application or are considering moving into this area. While preparing their applications, these companies will face a disparate range of requirements from the competent authorities in their respective federal states. Following intense preparation, official reviews and initial inspections of the companies’ QM systems and supply chain, many of these import permits and wholesale distribution authorisations will be granted without any major issues. In some cases, however, there may be some unwelcome surprises…  more >>
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Nitrosamines: EMA publishes list of potential contamination sources

Marketing authorisation holders (MAHs) currently need to test all chemically synthesised medicinal products for nitrosamine contamination. This requirement extends to innovative products, generics and over-the-counter (OTC) products alike. The EMA recently released a list of potential sources of nitrosamine impurities that can help MAHs to identify risks in the manufacturing process.  more >>
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Nitrosamine: MAHs have only six months of time remaining

Since contamination with nitrosamines caused recalls of yet another substance class a few days ago, the EMA has been concerned as to how far the range of nitrosamine-contaminated medicinal products extends and which products could still be susceptible to such contamination. It intends to obtain an assurance from every Marketing Authorisation Holder (MAH) that no nitrosamines are contained in finished products. MAHs should perform a risk assessment for all of their products within the next six months.  more >>
Middeler
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Increasing scarcity of notified bodies for medical devices – act now!

Medical device manufacturers who used to be able to rely on their notified body may soon find themselves without products. Manufacturers of medical devices composed of substances and combinations of substances that are being reassigned from class I to a higher medical device class are especially hard hit. They need product certification by a notified body for the first time, along with an audit of the quality management system according to EN ISO 13485:2016. But of formerly more than 80 notified bodies in Europe, many are no longer obtaining accreditation according to the MDR, which means they can no longer carry out such conformity assessments. Diapharm can help!  more >>
| Diapharm GmbH & Co. KG | Logo Diapharm GmbH & Co. KG | https://diapharm.co-operate.net

The pharmaceutical industry and Brexit – EU retesting within EU borders only from 1 January 2020

Batches of medicinal products to be marketed in the European Union must be tested and released by a QP in the EU27. The official post-Brexit grace period for companies that import medicinal products into the EU from or through the United Kingdom is going to be short. According to the CMDh, companies must have finished relocating their batch testing facilities to the EU27 by 1 January 2020 at the latest. Businesses that fail to comply will risk losing their marketing authorisation. International pharmaceutical companies that import medicinal products into the EU from third countries by way of the United Kingdom are just as affected as British manufacturers that have so far taken care of quality control and batch release for continental Europe within their national borders. Diapharm can help safeguard access to the European market in the short and long term.  more >>
Middeler
| Diapharm GmbH & Co. KG | Logo Diapharm GmbH & Co. KG | https://diapharm.co-operate.net

Diapharm secures market access for medical devices containing living microorganisms

Medical devices containing living microorganisms may still be placed on the market, even after 26 May 2020. Diapharm has won court proceedings ascertaining legal security: The transitional regulations of the Medical Device Regulation also apply to products containing living organisms like lactobacilli to restore the natural flora of the vagina and similar medical devices consisting of substances and combinations of substances.  more >>
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