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Pharmaceutical Drug Product Registration in Finland

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Pharmaceutical Drug Product Registration in Finland

Pharmaceutical Drug Product Registration in Finland

MOH

Ministry of Social Affairs and Health

MOH Website

https://stm.fi/en/frontpage 

Regulatory Authority 

The Finnish Medicines Agency Fimea  

Regulatory Website 

https://fimea.fi/

Local Authorized Representative Required

Yes

Drug Approval Process

A marketing authorization can be applied via the national, decentralized or mutual recognition procedure. Ex-ante control refers to the evaluation of data related to a marketing authorization application for a pharmaceutical. The pharmaceutical product must be effective, safe, and of sufficient quality to meet the requirements for a marketing authorization. 

This is evaluated by looking over the findings of clinical and non-clinical experiments done on the drug and reporting on the substance’s quality. Both an evaluation statement and a decision-making suggestion are based on this data.

  • Decentralized Procedure (DCP)

It is always possible to request that Fimea serve as a Reference Member State (RMS) for applications that are filed under the decentralized procedure (DCP). In about three to nine months, the applicants should be prepared to submit their application. The Decentralized Procedure (DP) can be used for medications that are not yet approved in the European Union. 

Manufacturers of these medications may submit simultaneous permission applications to several EU member states. This process is governed by Directive 2004/27/EC. Any state that is only one member of the DP may decide to evaluate the application on its own.

The Decentralized Procedure is divided in six steps:

1. Pre-procedural steps

2. Validation phase

3. Assessment step I

4. Assessment step II

5. Discussion at the CMDB, if needed

6. National step

  • Mutual Recognition Procedure

Market authorization issued in one EU member state is recognized in other EU member states under the Mutual Recognition Procedure (MRP). Only in cases where the manufacturer has already received market permission in an EU nation is MRP applicable. The Directive 2001/83/EC establishes the rules for market authorization through MRP. 

It is necessary to make sure that all MRP applications are comparable if they are sent to multiple EU nations. The nation reviewing the application is referred to as the Reference Member State, and it is its responsibility to inform the other relevant Member States of the application’s status. Finland can act as the Reference Member State (RMS) in the Mutual Recognition procedure when the product has first been granted a national marketing authorization in Finland.

  • National Procedure

The national procedure (NP) authorizes medications not covered by the centralized procedure or approved prior to the EMA’s formation. Manufacturers who want market authorization, particularly EU member states, can find it helpful. Applications in this procedure are examined by the relevant EU member state authorities. Every EU member state has its own national protocol.

  • Centralized Procedure

 Manufacturers can submit a single Market Authorization Application (MAA) to the EMA through the consolidated approach. Manufacturers who intend to sell their goods both inside the EU and in Iceland, Liechtenstein, and Norway—members of the European Economic Area (EEA)—will find the CP helpful. 

Following European Commission (EC) approval, producers can sell their products to healthcare professionals through a centralized mechanism under Regulation (EC) 726/2004.For each new application for a marketing authorization, the EMA designates a rapporteur and, if needed, a co-rapporteur under the centralized procedure. 

Along with their assessment teams, members or alternate members of the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) or Committee for Advanced Therapies (CAT) may serve as rapporteurs for human medications. Additionally, the Pharmacovigilance Risk Assessment Committee (PRAC) nominates a rapporteur and a co-rapporteur. 

Their job is to evaluate the plan for risk management. The objective is to choose the assessment teams with the greatest knowledge and experience about the marketing authorization application.

Documents Required for Pharmaceutical Drug Product Registration in Finland

1.Power of Attorney

2.Import License

3.European Drug Master File

4.Certificate of Suitability

Registration Timeline

  • National procedure: 210 days
  • Mutual recognition procedure: 90 days + 30 days for the review of translations
  • Decentralized procedure: 210 says + 30 days for the review of translations
  • Centralized procedure: 210 days + the time required by the decision process of the European Commission

Generic Drug Approval

A generic product means a pharmaceutical product that is similar in composition to the reference product in terms of the type and quantity of its active substances. The generic product shall also have the same pharmaceutical form as the reference product, and its bioequivalence shall have been demonstrated by means of appropriate studies in bioavailability or (in cases where bioequivalence cannot be determined) therapeutic equivalence. 

Unless they exhibit noticeably different safety or efficacious characteristics, the various salts, esters, ethers, isomers, mixes of isomers, complexes, and derivatives of the active ingredient in the generic product are regarded as the same active ingredient. In the event of the latter, the applicant must provide additional data regarding the various salts, esters, or derivatives of the active ingredient to demonstrate that there are no appreciable variations in safety or efficacy when compared to the reference product. 

Various oral pharmaceutical firms that provide instantaneous release of medicinal ingredients are regarded as equivalent pharmaceutical forms. The EMA committees for medical products, CHMP and CVMP, have provided appropriate rules that must be followed to demonstrate the bioequivalence of the generic product to the reference product. 

If the applicant for marketing authorization can show that the generic product satisfies the specifications outlined in these guidelines, bioavailability studies are not required.

Biologics

Biologically produced pharmaceuticals, and particularly those derived from biotechnology, are far more costly than conventional treatments. A reference to biosimilar products was incorporated into EU legislation in 2003, with the intention of limiting the rising cost pressure brought on by biological pharmaceutical products. 

The marketing authorization for biosimilar pharmaceuticals is partially derived from an original biological medical product, for which the patent and data have expired. Contrary to popular generic drugs, biosimilars need more thorough research than just quality and bioequivalence tests to be authorized for sale. 

This is because biologicals are heterogeneous, as was previously said, and controlling and analyzing them requires a variety of analytical techniques. The Biosimilar Working Party (BMWP), which is composed of Fimea scientists as well, oversees the guidelines.

Orphan Drug

The Regulation of Orphan Drugs came into force in the EU in April 2000 [Regulation (EC) No. 141/2000]. Pursuant to the Regulation, the European Medicines Agency grants orphan drug designations upon application for preparations that will be developed into drugs for treating rare diseases. The applications are assessed by the Committee for Orphan Medicinal Products (COMP).

The COMP meetings are where the applications are processed. An EMA coordinator and an assessor are assigned to each application. The application is processed in writing during the initial round of processing. If the application is accepted, written confirmation of acceptance is given. 

The applicant may be asked to provide written responses to any questions raised in the application or to appear in person at the next COMP meeting to answer any such questions. Following the hearing, the application is either approved or rejected. Throughout the process, the applicant can withdraw their application.

The granting of a marketing authorization for orphan drugs follows the same principles as in other medicine. The marketing authorization applications for orphan drug are always assessed using the centralized procedure. The assessors are experts representing the medicines agencies of different European countries.

License Validity

5 years

Registration Fee

EUR 18,750

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