Life Science Update: August 2021

Updated EMA Q&A with respect to the implementation of the MDR and IVDR 

The European Medicines Agency has issued an updated Q&A with respect to the implementation of the Medical Devices Regulation (Regulation (EU) 2017/745) (MDR) and the In Vitro Diagnostic Medical Devices Regulation (Regulation (EU) 2017/746) (IVDR). 

The Q&A covers:

• Medical devices that form an integral product with a medicinal product
• Medicinal products that include a medical device in the secondary packaging of the marketed medicinal product (co-packaged)
• Consultation procedures for ancillary medicinal substances that are an integral part of medical devices

 The updated Q&A was published on 23 June 2021 and can be found here.

Proposed amendment of the Danish act on a Medicinal Cannabis Pilot Programme

On 7 July 2021, the Danish Ministry of Health published for consultation a proposal for amendment of the Danish Act on a Medicinal Cannabis Pilot Programme. The background for the proposal is a political agreement for the continuation of the programme reached on 25 May 2021. 

The main elements of the proposal are the following:

• The current Medicinal Cannabis Pilot Programme, whereby doctors may prescribe products containing medicinal cannabis to patients, will be extended by four years, i.e. until 31 December 2025
• The scheme for companies to obtain a license to cultivate, manufacture and export medicinal cannabis products in and from Denmark will be made permanent
• The rules on reimbursement of patients' purchase of medicinal cannabis products will be repealed and replaced with an authorisation for the Minister for Health to regulate patients' reimbursement through executive legislation
• Medicinal cannabis companies manufacturing cannabis intermediate products will be required to include in the product packing an appropriate measuring device in certain instances where there are no applicable measuring devices on the market
• A number of provisions authorising the Minister for Health to introduce executive legislation on technical features will be transferred to the Danish Medicines Agency

The proposal can be accessed here (in Danish).

Proposed amendment of Danish acts following adoption of the Veterinary Medicines Regulation

Following the adoption of the new Veterinary Medicines Regulation (Regulation (EU) 2019/6), which will become applicable on 28 January 2022 and repeal the Veterinary Medicines Directive (Directive 2001/82/EC), the Danish Ministry of Health has published for consultation a proposal for amendment of the Danish Medicines Act, the Danish Pharmacy Act and the Danish Health Act. 

The proposal mainly entails that provisions which are covered by the Regulation will be removed from the Acts while provisions on areas left for national implementation will be adjusted in order to maintain the current state of the law.

However, on two areas the following amendments of the Acts are deemed necessary to comply with the Regulation:

• The rules governing online sales of non-prescription veterinary medicines will be amended so that private individuals may import non-prescription veterinary medicines to treat their own animals from other EU/EEC countries while pharmacies' right to sell veterinary medicines will be restricted to the Danish territory only
• The rules governing wholesale of certain substances will be amended so that such sales will require authorisation to conduct wholesale of medicines, while the registration scheme for the users in case of sale of such substances will be phased out

The proposal can be accessed here (in Danish).

Proposed adjustment of the Danish "SAD" (medicines produced in hospital pharmacies) scheme

On 7 July 2021, the Danish Ministry of Health published for consultation a proposal for amendment of the Danish Pharmacy Act to allow for the delivery of "SAD" medicines to private pharmacies by the hospital pharmacies, although similar medicines produced extemporaneously at private production pharmacies exist.

The proposal can be accessed here (in Danish).

Report from the European Commission on use of nanomaterials in cosmetics

The European Commission has issued a report which describes the current use of nanomaterials in cosmetic products on the EU market and reviews the provisions concerning nanomaterials in the Cosmetics Regulation (Regulation (EC) No 1223/2009), assessing whether said provisions are still fit for purpose in light of technical and scientific progress.

The review focuses in particular on the following aspects of the provisions:

• The definition of "nanomaterial"
• The notification process for cosmetics containing nanomaterials
• The scientific assessment of nanomaterials
• The labelling of cosmetics containing nanomaterials

The review highlights the differences between the definition of nanomaterials in the Cosmetics Regulation and Recommendation 2011/696/EU on the definition of nanomaterial, respectively, the definition in the Recommendation being applied in Regulation (EC) No 1907/2006 on Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH). According to the Commission, an alignment of the definition could increase coherence, but should be thoroughly assessed in order to evaluate its potential effects. Further, the review identifies shortcomings in the notification process for cosmetics containing nanomaterials that the Commission believes merit attention. Moreover, the review reveals that there is room for a strengthening of the scientific safety assessment of nanomaterials. Finally, the Commission suggests that digital labelling of cosmetics containing nanomaterials be considered.

The report was issued on 22 July 2021 and can be accessed here.

New guidance on placement of compulsory information in promotional material

In its newsletter dated 29 June 2021, the Danish Ethical Committee for the Pharmaceutical Industry (ENLI) has announced that it will update its Guidance on the ENLI Promotion Code to include guidance on the placement of compulsory information in promotion material where it may be difficult to place the information in the main material, i.e. as an integral part, such as podcasts or videos. ENLI highlights that the central aspect of the rules is that the compulsory information must not be separated from the promotional part. 

ENLI summarizes the main parts of the revised guidance as follows:

• The indication must always appear directly from the promotion material, i.e. the promotional part, unless the promotion material consists of a single paper with print on the front and back, in which case the indication may be placed on the back
• In promotion material presented in connection with e.g. the company's conferences, consultant's visits, website (provided that the material cannot be downloaded), emails to healthcare professionals (provided that the material cannot be downloaded) etc., compulsory information and references may be included via a link, which must be accessible through a single click
• The above guidance also applies in cases where the promotion material has been prepared by a third party

ENLI's newsletter can be found here (in Danish).

The Danish Medicines Agency strengthens its medical device inspection efforts 

Following the entry into force of the Medical Devices Regulation (MDR) on 26 May 2021, the Danish Medicines Agency has announced that it will strengthen its efforts with regard to inspection of medical device companies, having established a new inspection team specifically for this area. The Agency thus indicates that medical device companies in Denmark should likely expect an inspection in the coming years. In accordance with the MDR and IVDR, the Danish Medicines Agency will provide the EU Commission with final inspection reports following every inspection.

More information on the inspections, including practical information on how such inspections are carried out, can be found here (in Danish).

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