Commercialisation of healthcare in Sweden: overview
This article was originally published by Thomson Reuters Practical Law.
by Mina Gholiof, Hellström Law
A Q&A guide to the commercialisation of healthcare in Sweden.
This Q&A provides a high-level overview of the regulatory framework for the commercialisation of medical products in Sweden. It covers the key requirements for manufacturing, marketing, and advertising medicines, biological medicines, medical devices, combination products and natural health products.
1. What is the definition of medicine (or equivalent) in your jurisdiction?
A medicinal product is defined in Chapter 2, section 1 of the Swedish Medicinal Products Act (Läkemedelslag) (2015:315) (Medicinal Products Act) as any substance or combination of substances that either:
- Has properties to prevent or treat disease in humans or animals.
- Can be used on or added to humans or animals for the purpose of restoring, correcting or modifying physiological functions through pharmacological, immunological or metabolic effect, or for diagnosis.
2. What authorities are responsible for regulating the manufacture, marketing and advertising of medicines?
The responsible authority is the Swedish Medical Products Agency (Läkemedelsverket).
3. What notifications, registrations, approvals and licences are required to manufacture and market medicines and their active pharmaceutical ingredients?
Manufacturing
A party intending to manufacture medicinal products must obtain prior authorisation from the Swedish Medical Products Agency (Chapter 8, section 2, Medicinal Products Act). The Agency issues several types of permits and certificates for compliance with good manufacturing practice (GMP). A manufacturer of medicinal products must appoint at least one qualified person (an expert adviser) who holds an adequate level of education and experience. The qualified person is responsible for guaranteeing that each batch of medicinal products comply with GMP and meet the requirements of the medicinal product’s specific approval.Once authorised, the manufacturer must:
- Use in its manufacturing only active substances that have been:
- manufactured in accordance with GMP; and
- distributed in accordance with good distribution practice (GDP) for active substances.
- Immediately notify the Swedish Medical Products Agency and the holder of the authorisation for the sale of the medicinal product when the manufacturer receives information that a medicinal product covered by the manufacturing authorisation is, or is suspected to be, a falsified medicinal product.
- Verify that the manufacturers, importers or distributors of the active substances are notified to the Swedish Medical Products Agency in accordance with Chapter 10, section 2 of the Medicinal Products Act or with the competent authority within the European Economic Area (EEA).
- Verify the authenticity and quality of the active substances and excipients.
- Ensure that the excipients are suitable for use in medicinal products, apply GMP for excipients and document the measures.
(Chapter 8, section 3, Medicinal Products Act.)This applies to all professional manufacturing of medicinal products and intermediate products, as well as manufacturing of medicinal products covered by hospital exemptions. The manufacture of medicinal products for a specific occasion in a pharmacy or hospital pharmacy only requires a permit when the manufacture concerns medicines that are covered by hospital exemptions (Chapter 8, section 2, Medicinal Products Act).
Marketing
A marketing authorisation for a medicinal product is valid for five years after being issued and must be renewed after this period. There are four alternative procedures for marketing authorisation:
- Centralised procedure. Centralised marketing authorisation applications are assessed by the European Medicines Agency (EMA). Once granted by the European Commission, the centralised marketing authorisation is valid in all EEA member states (the EU member states plus the European Free Trade Association (EFTA) member states of Iceland, Norway and Liechtenstein). The centralised procedure is mandatory for some medicinal products, to ensure a high level of scientific evaluation and to ensure the availability of new, advanced medicines throughout the EEA. Medicinal products mandatorily subject to the centralised procedure include, among others:
- biotechnological products;
- orphan drugs;
- new active substances against cancer, AIDS, neurodegenerative diseases, diabetes, autoimmune diseases and viral diseases.
- Decentralised procedure. If the applicant does not hold a marketing authorisation in the EEA, the decentralised procedure allows the applicant to choose which countries the application will be sent to, and which country will be mainly responsible for the procedure (the reference country). The reference country conducts the main part of the investigation.
- Mutual recognition procedure. If the applicant holds a marketing authorisation in one or more countries in the EEA, the mutual recognition procedure allows the applicant to apply for marketing authorisation in other EEA countries based on the investigation conducted by the reference country (the country in which the marketing authorisation is already held). The mutual recognition procedure is also available for medicinal products that are approved through the national procedure (see below).
- National procedure. The national procedure is used in Sweden for medicinal products that are to be marketed and sold exclusively in Sweden. A party intending to market medicinal products in Sweden must obtain prior authorisation from the Swedish Medical Products Agency.
4. What are the differences between the regulation of new innovative medicines and generic or biosimilar versions of those medicines?
There are no major differences between the regulation of new innovative medicines and generic or biosimilar versions of those medicines. However, to obtain a marketing authorisation for a generic medicine, the Swedish Medical Products Agency may allow the requirement for documentation in the form of pre-clinical studies and clinical trials to be fully or partially fulfilled through submission of documentation concerning the reference medicine. This exception mainly applies where the reference medicine is or has been approved for at least eight years in an EEA country or the entire EEA (Chapter 4, section 13, Medicinal Products Act).
5. What are the differences between the regulation of prescription and over-the-counter medicines?
Prescription and over-the-counter medicines are subject to the same regulatory approvals. The main difference between the two relates to advertising. Over-the-counter medicines can be advertised to the general public, whereas prescription medicines can only be advertised to persons who are authorised to prescribe or dispense medicinal products. Neither type of medicine can be advertised to children (Chapter 12, section 2, Medicinal Products Act). See Question 8.