Pharmaceutical /Medicine/Drug/OTC registration in Sweden

MOH-Ministry of Health and Social Affairs

 MOH Website –https://www.government.se/

Regulatory Authority – Medical Products Agency

Regulatory Website-https://www.lakemedelsverket.se/en

 Local Authorized Representative Required-Yes

Drug Approval Process

• Centralized Procedure

  The European Medicines Agency (EMA) is responsible for coordinating centralised marketing authorization applications. Once approved by the European Commission, it is valid in all EU member states as well as Iceland, Liechtenstein and Norway.

  For some biotechnological goods, orphan medications, and novel active ingredients against cancer, AIDS, neurological diseases, diabetes, autoimmune disorders, and viral infections, the centralized process is required.

  This is done to assure access to both innovative and advanced medicines across the EU and a high level of scientific review.

  Centralized process is optional for certain items, but not for others.

  The application is sent to EMA, where it is reviewed by the Committee for Medicinal Products for Human Use (CHMP), which designates two National Competent Authorities (NCAs) who have expressed interest in serving as rapporteurs or co-rapporteurs based on their qualifications and the priorities of their country. Rapporteurs from the Pharmacovigilance Risk Assessment Committee (PRAC), one of EMA’s scientific committees, evaluate the risk management plan.

  Initially, the rapporteur countries evaluate the application in isolation from one another and produce separate reports. The reports are discussed by the other member nations and shared collectively. During a CHMP meeting, a common list of questions about uncertainties or flaws in the provided documentation is agreed upon by all member states. Usually within three to six months, the candidate responds to the inquiries.

  New assessments are started if objections persist. The applicant will receive a positive opinion from the CHMP and have their application forwarded to the European Commission for a decision if they adequately answer the questions and the benefit-risk balance is found to be positive.

  Sales in Iceland, Norway, Liechtenstein, and all other EU members are subject to the centralized approval process.If the CHMP evaluation is unfavorable, the applicant may ask for a reexamination or decide not to proceed with the application.

• Decentralized Process

  In the decentralized procedure (DCP), the medicinal product is not previously approved for the applicant in the EU nor Iceland, Liechtenstein and Norway. Applicants choose to which countries they want to submit their application and which one of these should take responsibility as the Reference Member State.

  The national authority that granted the applicant’s Request for Reference Member State (RMS) is the one responsible for conducting the primary evaluation of an application in DCP. Member States concerned (CMS) will be among the other nations involved in the process. Only after a time slot has been decided upon by the applicant and the potential RMS may an application be filed in DCP.

  The assessment process cannot last longer than 210 calendar days in total. The chance to add to an application based on RMS and CMS’s inquiries is provided to applicants. During what is known as a “clock-stop,” the applicant composes their response; this time is not part of the assessment. If the candidate provides complete answers to all inquiries and the benefit-risk ratio is deemed favorable, all participating nations concur on permission prior to end of Procedure.

• Mutual Recognition Procedure

  It is crucial that applicants think through whether any changes to the dossier are required to update it and make it compliant with current laws and regulations before submitting the request.

  Please be aware that before the request is submitted, any modifications must be approved. The request won’t be processed any further if there are still changes pending approval. There cannot be any changes made concurrently with the assessment report’s updating.

• National Procedure

  Before submitting the request, applicants must consider whether any changes to the dossier are necessary to update it and make it consistent with current laws and regulations.

  Please be advised that any changes must be approved before the request can be submitted. If revisions are still pending approval, the request will not be handled further. No modifications may be made while the evaluation report is being updated. After the application is filed, a 14-day validation process begins. To allow the procedure to begin, the application is checked in and the Swedish Medical Products Agency (Swedish MPA) confirms that the application is complete.

  STEP 1

  Day 0 marks the beginning of the process if the application is valid.

  On day 110, the primary assessment is finished, and the applicant receives a request for more information from the Swedish MPA. There is a 90-day window for responses.

  The primary response from the applicant will be their initial response. This response allows for the inclusion of fresh, thorough data. It is necessary to adhere to the 90-day response deadline. The Swedish MPA may decide to proceed with the application if no response is received within the allotted period.

  Extraordinary circumstances will result in the approval of an extended response deadline, provided that the request was made far enough ahead of the deadline.

  STEP 2

  Once a comprehensive response has been received, the process is resumed. Today is regarded as day 111. Complete responses are required for submission to the Swedish MPA; partial responses sent in various packets at different times will not be accepted. After responses are received, it is presumed that they are complete, and a new round is initiated.

  On day 165, the secondary assessment is finished. The Swedish MPA will email the applicant a request for more information if the application is not accepted. There is a 40-day window for responses.

  Only questions answered and explanations provided in the applicant’s second response will be accepted; then, additional, detailed data will not be accepted. The same idea underlies both centralized and decentralized processes.

  STEP 3

  Once a comprehensive response has been received, the process is resumed. Today is regarded as day 166.

  When the tertiary assessment is completed on day 190 and the application is still not approved:

  The Swedish MPA notifies the company that their application is about to be rejected and gives them the option to either withdraw it or inform them of the unresolved difficulties.

  In the third phase, the applicant is expected to respond as soon as possible to any unresolved questions. To allow approval by day 210, all unresolved concerns must be finished by day 195 at the latest.

  There won’t be another round where the response deadline is extended. The Swedish MPA prepares the decision after day 195, and it is transmitted by day 210.

  OTC Drug Registration

  Guidelines have been released by the European Commission to assist those requesting OTC status for human medication products. Applications for OTC status must meet the four requirements outlined in the guidelines for prescription-only use.

  There needs to be an English cover letter included with the application. The following must be included in the application:

• A clinical synopsis that incorporates a critical evaluation of the product’s safety and suitability for self-medication. The target population that has been approved must fit the parameters of the suggested indication. Should other comparable products be authorized for non-prescription usage, the suggested indication ought to align with the already approved. Any additional suggested dosage, indication, or package size needs to be supported in detail.
• For every product, a concise explanation of the application is required.
• Package mock-up, label, and leaflet proposed. There are OTC substance reports available for some substances that can be consulted regarding the substance and therapeutic area in question.

       License Validity – 5 years

       Registration Fee – 600 000 (Sek)