Marketing, Manufacturing, Packaging & Labeling, Advertising
A brief overview of the situation regarding marketing, manufacturing, packaging & labeling, advertising in Denmark. Prepared in association with Gorrissen Federspiel, a leading law firm in Denmark, this is an extract from The Pharma Legal Handbook: Denmark, available to purchase here for GBP 75.
1. What is the authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other medicinal products?
Please see Question 3 of Regulatory, Pricing and Reimbursement Overview.
2. What is the authorization process for the marketing of generic versions of these products?
An abridged procedure is available for marketing authorizations for generic medicinal products. Please see Question 6 of Regulatory, Pricing and Reimbursement Overview.
3. What are the typical fees for marketing approval?
Please see Question 4 of Regulatory, Pricing and Reimbursement Overview.
4. What is the period of authorization and the renewal process?
As a starting point, a marketing authorization for a medicinal product will be valid for 5 years. Please see Question 5 of Regulatory, Pricing and Reimbursement Overview.
5. What are the requirements, if any, for post-approval pharmacovigilance?
Please see Question 8 of Regulatory, Pricing and Reimbursement Overview.
6. Are foreign marketing authorizations recognized?
Please see Question 6 of Regulatory, Pricing and Reimbursement Overview.
7. Are parallel imports of medicines or devices allowed?
Parallel import, i.e. the import of medicinal products that have already received a marketing authorization from the DKMA via other distribution channels than the ones approved by the rights holder, is monitored by the DKMA.
The DKMA may grant an authorization for parallel import, provided i) the medicinal product, in relation to which an application for parallel import has been made, must be covered by a valid marketing authorization in Denmark, ii) the parallel imported medicinal product must be imported from an EU/EEA country, iii) the parallel imported medicinal product must be covered by a valid marketing authorization from an EU/EEA country, and iv) there must not be any significant therapeutic differences between the medicinal product that is directly distributed and the parallel imported medicinal product.
An authorization for a parallel import authorization must also be obtained in each country of export.
For centrally authorised medicinal products that are imported into Denmark (parallel distribution), there is not a requirement that the products must receive a separate marketing authorisation. However, the Danish parallel distributor must register with the DKMA.
Medical devices are not subject to an authorisation by a governmental agency. Thus, if a medical device has been affixed with a CE mark and is lawfully marketed in another EU/EEA country, then the medical device can be imported into Denmark (provided certain Danish language and labelling requirements are met). However, there are certain restrictions as to re-packaging of medical devices. If a parallel distributor enters into the areas that fall under the manufacturers responsibility (e.g. if the parallel distributor opens or re-package the imported products), then the parallel distributor will assume the full responsibility for the devices as a manufacturer.
8. What are the restrictions on marketing practices such as gifts, sponsorships, consultancy agreements, travel and entertainment, or other incentives for healthcare organizations and individual medical practitioners?
For medicinal products, the rules governing marketing practices such as gifts, sponsorships, consultancy agreements, hospitality, etc., towards healthcare professionals etc., are set out mainly in the Danish Medicines Act and the Danish Executive Order on Advertising of Medicinal Products (Executive Order no. 1153 of 22 November 2014, “Advertising Order”).
Furthermore, the industry codes and guidelines published by the Ethical Committee for the Pharmaceutical Industry in Denmark (“ENLI”) also contain detailed restrictions on such practices when directed towards healthcare professionals. ENLI has issued the Pharmaceutical Industry’s Code of Practice on Advertising, etc. of Medicinal Products aimed at Healthcare Professionals (“Promotion Code”). ENLI’s rules, including the Promotion Code, apply to:
- Members of the Danish Association of the Pharmaceutical Industry,
- Members of the Danish Generic and Biosimilar Medicines Industry Association,
- Members of the Danish Parallel Importers’ Association,
- Other companies that have accepted to be bound by ENLI’s rules.
For medical devices, the relevant restrictions are set out in the Act on Medical Devices and the Danish Executive Order on Advertising of Medical Devices (Executive Order no. 1155 of 22 October 2014).
Gifts, sponsorships, consultancy and hospitality
As a starting point, the provision or offering of financial benefits to healthcare professionals – including gifts – is prohibited.
A limited number of exemption to this general prohibition apply.
For example, it may be lawful to provide gifts if these are of an insignificant value and can be used in the recipient’s practice. According to the guidelines on the Advertising Order and the Executive Order on Advertising of Medical devices, the term “insignificant value” is construed as meaning a value not exceeding DKK 300 in a given calendar year.
As another exemption to the general prohibition, it is permitted to provide healthcare professionals reasonably payment in return for professional services if such payment is proportionate to the services offered.
It is also permitted to provide payment for direct expenses in connection with professionally relevant courses, conferences and supplementary training attended or conducted by healthcare professionals, and to provide payment for direct expenses for meals, travel and accommodation in connection with advertising of or professional information on medicinal products and medical devices.
Notification, Disclosure and transparency
Relationships and collaborations (“affiliations”) between pharmaceutical companies/medical devices companies and healthcare professionals must – depending on the nature of the relationship in question – be either notified to or approved by the DKMA.
The rules on affiliations apply to i) pharmaceutical companies that have a marketing authorization pursuant to Section 7 of the Danish Medicines Act or an authorization to manufacture, import, export, store and distribute, etc. medicinal products pursuant to Section 39 of the Danish Medicines Act,, ii) manufacturers (representatives), importers and distributors that are established in Denmark and that market medical devices within classes IIa, IIb, III or in vitro diagnostic devices or active implantable devices, and iii) stores specialised in sale of medical devices that are established in Denmark. Such companies are required to notify the DKMA when establishing affiliations with HCPs. Likewise, the HCPs must notify or seek approval from the DKMA of the affiliation with the above-listed companies.
Information on relationships and collaboration must be disclosed to the DKMA and will also be published by the DKMA.
With respect to the rules on affiliations, please see question 66 below on the upcoming amendments to the rules on affiliations between pharmaceutical companies and medical devices companies and healthcare professionals, which will lead to an expansion of the group of companies that are subject to the rules on affiliations.
In addition to the rules on affiliations, the pharmaceutical companies and medical device companies must also inform healthcare professionals (and certain specialists engaging in the buying and selling of medical devices) of such persons’ duty to inform the Danish Medicines Agency about financial support received from a pharmaceutical company or a medical device company in connection with participation in professional events abroad. Please see question 66 below on the upcoming amendments to the rules concerning financial benefits.
9. How is the manufacturing of medicines and devices regulated and by which agencies?
Please see Question 3 of Regulatory, Pricing and Reimbursement Overview.
10. Are local manufacturing requirements compatible with Good Manufacturing Practices (GMPs) as defined by the U.S. Food & Drug Administration and/or the European Medicines Agency?
Yes. The Danish Executive Order on Manufacture and Import of medicinal products and intermediary products (Executive Order no. 1358 of 18 December 2012, “GMP Order”) contains provisions implementing the EU directives on good manufacturing practice in respect of medicinal products.
11. What is the inspection regime for manufacturing facilities?
Please see Question 8 of Regulatory, Pricing and Reimbursement Overview.
12. Are manufacturing facilities open for inspection by foreign inspectors or third-party inspectors as authorized by the FDA/EMA?
Since 2018, Denmark has been covered by the mutual recognition agreement between the regulatory authorities in the EU and the US, which means that the authority may rely on each other’s GMP inspection systems.
13. What are the requirements for storage, packaging, and handling of medicines and devices and their constituent components?
The Danish rules on GMP, including the Danish GMP Order include requirements on storage, packaging and handling of medicinal products.
14. What information must be included in medicine and device labeling?
Pursuant to the Danish Executive Order on Labelling Of Medicinal Products (Executive Order no. 869 of 21 July 2011 on labelling of medicinal products, “Labelling Order”), the labelling of medicinal products must include, i.a.,:
- The name of the medicinal products,
- The strength of the product,
- The pharmaceutical form,
- Contents by weight, volume or doses,
- A statement of the active substances,
- Method of administration and if necessary route of administration,
- Warnings regarding storage,
- Batch number and expiry date,
- Name and address of the holder of the marketing authorization,
- Specific precautions relating to the disposal of unused medicinal products or waste,
Additional labelling requirements may apply to herbal medicinal products. The Labelling Order also provides that as a rule all labelling as well the patient information leaflets must be provided in Danish.
For medical devices, the labelling must include the following information:
- Name and address of the EU manufacturer (in case of a non-EU manufacturer both the name and address of the non-EU manufacturer and its EU representative must be listed),
- Information necessary for identifying the device,
- The purpose of the device,
- Information on batch number, expiry date, date of manufacture, indications that the device is meant solely for clinical trials, CE-marking, number of the notified body, if relevant,
- Information on handling and storage,
- Precautions and warnings,
The labelling and instructions for use of all medical devices must be in Danish, when the device is made available to any end user in the Danish market. Under certain circumstances, the DKMA can grant exemptions from the language requirement.
15. What additional information may be included in labeling and packaging?
Additional labelling may be included if the information is of a non-promotional nature, does not mislead and does not compromise user safety, readability, and is in accordance with the SmPC.
16. What items may not be included in labeling and packaging?
For medicinal products, the labelling may not contain elements of a promotional nature.
Furthermore, the labelling must not be misleading or make the product susceptible of confusion with other medicinal products, types or strengths.
17. What are the restrictions and requirements for the marketing and advertising of medicines and devices?
The Danish Medicines Act provides that advertising of a medicinal product shall be adequate and objective, and must not mislead or exaggerate the characteristics of the medicinal product. The information provided in connection with advertising must be in accordance with the authorised SmPC.
In Denmark, prescription medicinal products may not be advertised towards the general public, but only towards healthcare professionals (defined broadly as doctors, dentists, veterinarians, pharmacists, nurses, veterinary nurses, pharmaconomists or students within one of these fields).
Advertising towards the general public must not, i.a.:
- give the impression that it is not necessary to consult a healthcare professional,
- give the impression that use of the medicinal product is safe, without side effect or better than or just as good as the effect of another treatment or another medicinal product,
- give the impression that average well-being can improve by use of the product, or that the average well-being can decrease if the product is not used,
- only or mainly be directed towards children,
- contain a recommendation from healthcare professionals, scientists or other persons, unions of persons, institutions, companies or the like that could induce the use of medicinal products via their standing,
- give the medicinal product equal status with food, cosmetics or other consumer goods,
- contain exaggerating, scary or misleading statements on cure,
- make exaggerating, scary or misleading use of visual presentations of changes in the human body caused by diseases or injuries or of a medicinal product’s effects on the human body or parts thereof.
Specific requirements apply with regard to advertising in film, on the radio, and in the television, and with regard to advertising directed towards healthcare professionals.
For medical devices, the advertising must also be adequate and objective, and must not be misleading or exaggerating. The information must be in accordance with purpose and scope of use of the device and it must be verifiable, and it must not constitute a risk to the health and safety of patients, users or any third persons.
The majority of the prohibited elements listed above for medicinal products also apply with regard to advertising of medical devices.
18. Where can medicines and devices be sold or delivered? Can medicines and devices be sold or delivered via post?
As a starting point, pharmacies have the exclusive right to sell prescription medicines to end users. Likewise, a number of over-the-counter/non-prescription medicinal products may only be sold at the pharmacies.
The DKMA may decide that certain over-the-counter medicinal products are to be exempted from the pharmacies’ exclusivity. Such medicinal products may be sold to end users by authorised retail sellers outside pharmacies.
Danish pharmacies and authorised retail sellers are permitted to sell prescription only-products and over-the-counter products online. Prescription only-products are sold on the basis of electronic prescriptions, which are issued electronically in “The Shared Medicine Card” (a central database monitored by the Danish Health Data Authority). Products bought online may be distributed by mail or courier services.
Medical devices may be sold in specialized stores (stores specialized in medical devices within class IIa, IIb and III, active implantable devices and devices for in vitro diagnostics) or in normal retail stores. Specialized stores must be registered by the DKMA.
Medical devices may be sold online.
19. What are the restrictions and requirements for electronic marketing and advertising via email, by Internet, social media, and other channels?
The rules and restrictions applicable to advertising of medicinal products and medical devices also apply to advertising on the internet, on social media, etc.
For medicinal products, it should be noted that advertising on the internet will be considered as directed towards the general public, unless access to the content is restricted in a securely and effective manner to healthcare professionals only.
With regard to advertising by way of e-mail or by way of direct messaging on social media, the restrictions of the Danish Marketing Practices Act (Consolidated Act no. 426 of 3 May 2017) on unsolicited marketing communication apply.
20. May medicines and devices be advertised or sold directly to consumers?
Please see Questions 17 and 18 above.
21. How is compliance monitored?
The DKMA and the Danish Ministry of Health monitors compliance with the rules on manufacture, packaging, labelling and advertising.
In practice, disputes regarding the advertising of medicinal products directed at healthcare professionals may also be brought before the self-regulatory body within the pharmaceutical industry.
22. What are the potential penalties for noncompliance?
Violation of the rules on advertising is subject to fines. The DKMA may also issue orders to the effect that the non-compliant advertising must be stopped, materials withdrawn and rectified.