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How long does it take, in general, to obtain an authorisation from application to grant, what fees are payable and what is the normal period of validity of the authorisation?
The average processing time for a fully documented application under the national procedure is around 200 days from submission of application to grant. The fee by the Danish Medicines Agency (DMA) for a fully documented application under the national procedure is 314,895 Danish kroner, pursuant to Executive Order No. 729 of 30 May 2022 on the fees for medicinal products and companies, among others. The fee for a fully documented application under the decentralised procedure and the mutual recognition procedure is 364,763 Danish kroner.
A marketing authorisation must be renewed after five years. The renewal application must be submitted no later than nine months before the expiry of the authorisation. Once renewed, it is valid for an unlimited period of time unless the DMA decides that an additional five-year renewal is required.
The renewal fee to be paid for an application under the national procedure is 5,684 Danish kroner.
What protections or exclusivities apply to the data submitted by originators to gain initial approval and, on variation or new application, to add indications or pharmaceutical forms?
Data submitted by originators under a full-dossier application enjoy eight years of data exclusivity, protecting them against the filing of generic or biosimilar applications.
There exists no data protection for medical devices similar to the protection for medicinal products.
To what extent and when can third parties make freedom of information applications for copies of research data submitted by applicants for authorisation to market medicinal products or medical devices?
In accordance with the Freedom of Information Act 2020, third parties may apply for access to research data when the research data is submitted to the DMA as part of an application for marketing authorisation for a medicinal product. However, the applicant for marketing authorisation (if granted, the marketing authorisation holder) may object to the disclosure of the information, for example, on the grounds that the information contains:
An assessment must be made on a case-by-case basis on whether these exemptions apply.
As for medical devices, marketing authorisation from the DMA is not a requirement to place a device on the Danish market and third parties cannot obtain research data by way of a freedom of information application to the DMA.
What are the specific requirements and processes for marketing approval of the major categories of regulated products?
Traditional herbal medicines must be approved by the DMA before being marketed. If certain requirements are fulfilled, the application process may follow a special procedure where the documentation requirements are less stringent than those for ordinary medicinal products.
Likewise, homeopathic products that fulfil certain criteria may be approved under a special simplified procedure (registration) where no evidence of therapeutic effect is required.
Application for marketing authorisation for biotechnological medicines (including biosimilars) must be submitted to the European Medicines Agency under the centralised application procedure.
Regulation (EC) No. 1901/2006 of 12 December 2006 on medicinal products for paediatric use provides special incentives and rewards to develop and market those medicinal products. The same is true for orphan drugs, which may be authorised under the special procedure under Regulation (EC) No. 141/2000 of 16 December 1999 on orphan drugs. See the chapter on the European Union for more information.
In addition, since 1 January 2018, a special Danish pilot programme for medical cannabis has been in place. The Danish parliament has recently agreed to prolong part of the programme and make another part permanent.
What pharmacovigilance or device vigilance obligations apply to the holder of a relevant authorisation once the product is placed on the market?
A market authorisation holder must operate a pharmacovigilance system to:
This entails appointing a qualified person responsible for pharmacovigilance who must meet certain requirements in respect of education and qualification, and reside in the European Union.
Among other things, the marketing authorisation holder must:
Manufacturers of medical devices also must put in place quality management and post-market surveillance systems proportionate to the risk class and the type of device. The surveillance and vigilance requirements have become stricter with the Regulation (EU) 2017/745 on medical devices. The new rules include the requirement to prepare a periodic safety update report and a post-market clinical follow-up. See the chapter on the European Union for further details.
What authorisations are required to manufacture, import, export or conduct wholesale distribution and storage of medicinal products and medical devices? What type of information needs to be provided to the authorities with an application, what are the fees, and what is the normal period of validity?
The manufacture or import of medicinal products requires a manufacturing and importation authorisation (MIA) from the DMA. The information to be provided with the application includes:
The DMA charges both application and annual fees for its services. In 2022, the application fee for obtaining an MIA is 74,298 Danish kroner while the annual fee is 66,395 Danish kroner (the application fee and the annual fee will both amount to 74,298 Danish kroner in 2023), pursuant to Executive Order No. 729 of 30 May 2022 on fees for medicinal products and companies, among others.
Wholesale distribution and storage of medicinal products require wholesale distribution authorisation (WDA) from the DMA, which is granted for specifically identified premises. The information to be provided with the application includes:
In 2022, the fee for obtaining a WDA is 25,915 Danish kroner, while the annual fee is 22,456 Danish kroner (the application fee and the annual fee will both amount to 25,915 Danish kroner in 2023).
The export of medicinal products to third countries outside the European Union and the European Economic Area (EEA) requires a WDA from the DMA. The export of medicinal products manufactured by the exporting company itself is included in an MIA.
On 1 September 2012, the DMA changed its practice so that company authorisations are no longer issued with an expiry date. Therefore, an authorisation is valid until it is amended or terminated. Companies holding an authorisation with an expiry date must apply for renewal within six months and no later than three months before the expiry date.
No authorisations are required from the DMA to manufacture, import, export or conduct wholesale distribution and storage of medical devices. However, registration with the DMA is required.
The DMA charges a registration fee of:
Additionally, the DMA charges two annual fees. The first fee varies for manufacturers between 4,551 kroner and 263,651 kroner, depending on the risk class of the medical device and on the number of employees of the company registered in the Central Business Register on 31 January in the relevant calendar year. For importers and distributors, the fee varies between 3,929 kroner and 233,774 kroner. The second fee amounts to 1,223 kroner. The fees are adjusted annually.
Medical device manufacturers and other medical device operators (such as distributors and importers of medical devices) are not required to obtain similar authorisations. However, manufacturers and certain other medical device operators must register themselves with the DMA (or with the European Database on Medical Devices, known as Eudamed, where applicable) before marketing medical devices in Denmark. Furthermore, such companies must observe procedures for conformity assessment and post-market surveillance.
What civil, administrative or criminal sanctions can authorities impose on entities or their directors and officers for breach of the requirements concerning controlled activities?
The sanctions vary from fines and injunctions to withdrawal of authorisations and imprisonment depending on the type and severity of the violation. The DMA may, for example:
Directors and officers of companies that do not comply with the regulation – for example, by manufacturing medicinal products without a valid manufacturing authorisation – may be punished with a fine or up to 18 months’ imprisonment.
For medical devices, if the notified body (ie, the entity responsible for the assessment of whether a medical device can be 'CE' marked) becomes aware that a manufacturer of a medical device does not comply with the legislative requirements, it may limit, suspend or withdraw the certificate of the relevant device’s 'CE' marking.
The sanctions vary from fines and injunctions to prohibitions on marketing and market recalls. For example, if the DMA becomes aware that the 'CE' mark has been placed on a medical device illegitimately, the DMA may order the manufacturer or its representative to remedy the violation, limit or prohibit the marketing of the product, or arrange for its withdrawal from the market.
Directors and officers of companies that do not comply with the regulation – for example, by not complying with an injunction – may be punished by a fine or up to 18 months’ imprisonment.
What, if any, manufacture and supply of medicinal products is exempt from the requirement to obtain an approval to market?
Marketing authorisation is not required for the manufacture and supply of medicinal products prepared at a pharmacy to an individual patient on the prescription of a physician (magistral medicines).
Pharmacies must, however, not manufacture or supply magistral medicines if a medicinal product with a similar therapeutic effect is marketed and available in Denmark. In certain situations, the DMA may, upon application by the patient’s physician, authorise a pharmacy to manufacture a magistral medicinal product even though the magistral medicine has the same therapeutic effect as a medicinal product already marketed in Denmark.
Are imports allowed into your jurisdiction of finished products already authorised in another jurisdiction, without the importer having to provide the full particulars normally required to obtain an authorisation to market? What are the requirements?
Parallel imports of medicinal products from other EU and EEA member states are allowed subject to an authorisation issued by the DMA.
An applicant for an authorisation to market parallel imported medicinal products does not have to provide full documentation when the DMA has already issued a marketing authorisation for the directly traded medicinal product.
The DMA can issue a marketing authorisation for parallel imports under the following requirements:
The marketing authorisation is valid for five years and may be continuously renewed for further five-year periods.
The originator must be informed of the contemplated parallel import.
Parallel distribution of medicinal products that have been authorised by the European Commission under the centralised authorisation procedure does not require a separate Danish marketing authorisation. The parallel distributor must notify the EMA of the intended parallel distribution and await its confirmation that parallel distribution of the product is permitted.
As for medical devices, marketing authorisation from the DMA is not required for parallel import. When a medical device is duly 'CE' marked, it can be marketed on the Danish market without any national approval. However, the parallel importer must register with the DMA and ensure that all information, both printed and electronic, is in Danish at the time that the medical device is made available to the end user.
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