How long does it generally take to obtain a permit from the grant application, what fees must be paid and what is the normal period of validity of the approval?
In Sweden, as part of the European Union, an application for a marketing authorization for a medicinal product can be made using four different procedures:
- a centralized process;
- a mutual recognition procedure;
- a decentralized procedure; and
- a national procedure.
In the centralized procedure, the assessment is made by two national competent authorities appointed by the Committee for Medicinal Products for Human Use. The assessment must be completed within 210 days. The final opinion is forwarded to the European Commission for decision. Authorization of medicinal products through the centralized procedure entitles the undertakings concerned to sell these products throughout the European Economic Area (EEA).
Through the mutual recognition procedure, an undertaking may request that an existing national permit be recognized in other EEA countries. The application is assessed by the competent authority where the authorization has already been granted (reference Member State (RMS)) and the competent authority of the country where the authorization is to be extended (Member State concerned (CMS)). The total treatment time must not exceed 90 days. The general application fee for a complete application is SEK 120,000 when Sweden is CMS and SEK 200,000 when Sweden is RMS. An extension of an existing permit is SEK 200,000 if Sweden is RMS or SEK 65,000 if Sweden is CMS. There is also an annual fee that generally amounts to 51,000 Swedish kronor for approved drugs.
The decentralized procedure is applicable in cases where a company wishes to obtain a marketing authorization in a number of EEA countries for a medicinal product that does not have a previous authorization. The application is assessed and approved by an RMS selected by the company and approved at the same time by CMS. The assessment must be completed within 210 days. The application fees are the same as for the mutual recognition procedure.
Through the national procedure, one can only be granted the right to market in a single country. The assessment by the Medical Products Agency (MPA) must be completed within 210 days after the MPA has validated the application as complete (the validation period is 14 days). The general application fee is SEK 500,000, an extension of an existing permit amounts to SEK 200,000 and the annual fee amounts to SEK 51,000.
There is no requirement for a sales permit for medical devices. For current registrations regarding medical equipment, the following applies to IVD products and older products. The company registration fee is SEK 2,150 per year. Annual registration fees for products are as follows:
- for 10 products: 1,000 Swedish kronor;
- for 100 products: SEK 2,000;
- for 500 products; 5,000 Swedish kronor; and
- for more than 500 products: 10,000 Swedish kronor.
The Swedish fee system for medical devices placed on the market in accordance with EU Regulation 2017/745 of 5 April 2017 on medical devices (MDR) and EU Regulation 2017/746 from the European Parliament and the Council of 5 April 2017 on medical devices for in vitro diagnostics (IVDR) is being revised, which will surely lead to higher annual fees than those mentioned above.
Protect research data
What protection or exclusivity applies to information provided by authors to obtain initial approval and, in the case of variation or new application, to add indications or drug forms?
Data exclusivity is governed by EU Regulation (EC) No 726/2004 (see Chapter of the European Union).
Freedom of information
To what extent and when can third parties apply for freedom of information for copies of research data submitted by applicants for authorization to market medicinal products or medical devices?
This is regulated by EU Regulation (EC) No 726/2004; see the chapter on the European Union.
Regulation of specific drugs
Are there specific rules for authorization and rewards or incentives for the authorization of specific types of drugs, such as traditional herbal and homeopathic products, biological and biosimilar, controlled drugs, orphan drugs and those for children?
MPA regulation HSLF-FS 2017: 75 must be followed when registering homeopathic medicines. The Regulation is based on the relevant provisions of EU Directive 2001/83 / EC (Medicines Directive).
In the case of herbal medicinal products (ie medicinal products in which the active ingredient consists exclusively of herbal medicinal products or herbal preparations), these are also covered by the scope of the Medicines Directive. In addition, the MPA regulation LVFS 2006: 3 applies.
With regard to biological and biosimilar properties, the criteria for approval are set out in various guidance documents issued by the European Medicines Agency (EMA).
For orphan medicinal products and products for pediatric use, see the EU chapter.
Post-marketing surveillance of security
What obligations for pharmacovigilance or surveillance apply to the holder of a relevant authorization when the product is placed on the market?
For medicines, a requirement is required for updating product information in relation to new knowledge. In the event of non-compliance, the MPA may submit a request for verification after approval of a medicinal product requiring updates. Failure to respond to such a request may result in an injunction and other consequences, such as deregistration of the product.
Furthermore, there is a requirement for periodic security update recording in accordance with Regulation (EU) No 1235/2010, Directive 2010/84 / EU and Commission Implementing Regulation (EU) No 520/2012, implemented by the MPA Regulation LVFS 2012: 14. See EU – chapter for more information on periodically recording security updates.
For medical devices, manufacturers are required to continuously monitor the performance of their products in practical use and are required, for example, to report any serious incidents involving devices or any error-correcting devices, according to MDR and IVDR, see Chapter of the European Union (during the transitional period in the Medical Devices Act and the relevant MPA Regulation).
What permits are required to manufacture, import, export or conduct wholesale distribution and storage of pharmaceuticals and medical devices? What type of information must be provided to the authorities with an application, what are the fees and what is the normal period of validity?
For medicines, a license from MPA is required for the manufacture, import from and export to a country outside the EEA of medicines in accordance with the Pharmaceuticals Act. The requirements for the permit are found in the MPA regulation LVFS 2004: 7. For example, the application must contain:
- general information about the applicant (eg name, registration certificate and billing address);
- if the application concerns a particular drug or drugs in general.
- form of drugs or products;
- the location of the premises;
- details of premises and equipment;
- a description of possible contract manufacturing or contract analysis; and
- a proposal for an expert or advisor and his or her curriculum vitae.
Decisions on an application should generally be made by the MPA within 30 days of the submission of a complete application (this period may be extended to 90 days). The general application fee for manufacturing is SEK 65,000 and the annual fee is generally SEK 60,000 to SEK 80,000. The license is valid as long as the annual fees are paid, but not for a longer period than stated in the decision. An application for a wholesale license costs SEK 40,000 and an annual fee of SEK 13,500 must be paid.
No Swedish license is required for the manufacture or import of medical devices for medical equipment. Of course, and in accordance with MDR, IVDR and medical device directives, medical device products with the appropriate CE marking can be exported freely within the EEA. However, countries outside the EEA can request a “free sales certificate”, which ensures that the product can be exported without any legal restrictions. MPA can issue such certificates. The application fee is 950 Swedish kronor. The period of validity is usually three years or the period of time for CE marking.
What civil, administrative or criminal sanctions can the authorities impose on entities or their directors and officials for breaches of the requirements for controlled activities?
The MPA has the power to issue the injunctions and prohibitions necessary to ensure compliance with the Medicines Act and certain provisions of the MDR and IVDR (or the Medical Technology Act during the transitional period) and may combine such injunctions with fines.
In the case of criminal sanctions, violations of the Medicines Act and certain provisions of the MDR and IVDR (or the Medical Technology Act during the transitional period) are punishable by a fine or imprisonment for a maximum of one year.
What, if any, the manufacture and supply of medicines are exempt from the requirement to obtain a marketing authorization?
There is an exception to the requirement for a marketing authorization for advanced therapy medicinal products as defined in Article 2 of EU Regulation (EC) No 1394/2007, produced in Sweden in accordance with a non-routine procedure, for a specific patient in accordance with with a prescription, and which is used in Swedish hospitals. A license is required in accordance with the Pharmaceuticals Act and the Medical Products Agency (MPA) regulation LVFS 2011: 3.
Individual licenses regulated by the MPA regulation HSLF-FS 2018: 25 and extemporaneous medicines as well as stock preparations produced by a pharmacy are also exempt from the requirement for approval for sale. Pharmaceutical products, stock preparations and national licenses for stock preparations of more than 1,000 products per year are mainly regulated by the MPA regulations LVFS 2008: 1, LVFS 2010: 12, LVFS 2010: 4, LVFS 2004: 7, LVFS 2009: 8 and HSLF-FS 2018: 26.
Are imports permitted in your jurisdiction of finished products already approved in another jurisdiction, without the importer having to provide the complete information normally required to obtain a marketing authorization? What are the requirements?
Parallel import of medicines from other EEA countries to Sweden (which has been approved in the other EEA country through the national procedure, the mutual recognition procedure or the decentralized procedure) is permitted but requires permission from MPA in accordance with Regulation LVFS 2012: 19, and must comply with the labeling requirements of the Regulation. Medicines that have been approved through the central procedure can instead be distributed in parallel, which is approved by the EMA (see chapter in the European Union).
Parallel import of medical equipment does not require permission from MPA. however, the importer must comply with the requirements of the MDR and IVDR (or Medical Devices Act and applicable MPA Regulation during the transitional period). Furthermore, all labeling and instructions for the use of medical devices must be written in Swedish.