The documentation relating to the application shall be submitted electronically. The part of the documentation that contains technical and scientific data may be submitted in English.
The information to be handed out to trial subjects must be available in a Swedish version. If the same documentation has been sent to the Medical Products Agency at an earlier occasion, it is sufficient to provide clear reference to when and in which context it was submitted. If certain documentation is omitted, a justification should be provided.
In all contacts with the Medical Products Agency the applicant is requested to state the EudraCT number.
- Covering letter. The covering letter should draw attention to any special issues related to the application such as special trial populations, whether it is the first administration of a new active substance to humans, whether it is a resubmission etc. In addition, any scientific advice related to the trial or the IMP (provided by the EMEA, MPA or the competent authority of any other country) should be mentioned and a copy of the advice submitted.
- Application form signed by the sponsor/applicant. The application form is the same for all Member States and can be obtained from the EudraCT Website (external link to the right). The application form shall be submitted electronically as an XML file and, in writing in one original and five copies. To facilitate our validation of the application please submit section J, as well.
- Protocol signed by the sponsor and the principal investigator (or, for multi-centre trial, the co-ordinating investigator). The content and format of the protocol should comply with the guidance in the guideline on Good Clinical Practice (CPMP/ICH/135/95). The protocol version submitted should include all currently authorized amendments.
- Investigator’s Brochure. The contents, format and also the procedures for updating the IB should be in accordance with the guideline on Good Clinical practice (CPMP/ICH/135/95). To facilitate the non-clinical assessment it is requested that the Investigator’s Brochure and, when applicable, also the non-clinical part of the IMPD, is submitted not only in writing but also as an electronic copy on a disc as a Microsoft Word document (Microsoft Word 2003 or later versions).
- Investigational Medicinal Product Dossier, IMPD (Full or Simplified). For more information on when to submit a full or a simplified IMPD see table 1 in the Commission guidelines on the request for authorization of clinical trials.
- Overall risk benefit assessment. An evaluation of the anticipated benefits and risks as required in the Commission guidelines on the request for authorization of clinical trials, and in Article 3(2)(a) of the Directive 2001/20/EC.
- Copy of ethics committee opinion when available. The review of the application by the Medical Products Agency and the Ethics Committee may occur in parallel or in sequence. It is the responsibility of the sponsor to ensure that a copy of the Ethics Committee’s opinion is submitted to the Medical Products Agency within 15 days upon receival.
- Copy of the manufacturing authorization, certification of GMP status or equivalent.
- Qualified Person (QP) Declaration if applicable. For more information see the section on GMP (internal link to the left).
- The content of the labelling of the IMP in Swedish. The label text may be accepted in English provided that the medicinal products will be handled solely by health care professionals at the investigational site. Guidance regarding labelling of IMPs is given in Annex 13 (EudraLex Vol. 4, GMP Guidelines, external link to the right). National regulations are also given in LVFS 2003:6.
- Additional requirements (if applicable). For investigational medicinal products with certain characteristics, e.g. products that consist of, or contain, genetically modified organisms there are additional requirements provided in the Ordinance (2002:1086). When genetically modified organisms are included in a clinical trial, the Ordinance (2002:1086) represents the Swedish implementation of Directive 2001/18/EC. For the deliberate release of genetically modified organisms into the environment a special permission is required from the Medical Products Agency.