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Pharmaceutical Drug Product Registration in Latvia

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Pharmaceutical Drug Product Registration in Latvia

Pharmaceutical Product Registration in Latvia

MOH

Ministry of Health

MOH Website

http://www.nefmi.gov.hu/egeszsegugy

Regulatory Authority 

National Institute of Pharmacy and Nutrition

Regulatory Website 

https://ogyei.gov.hu/

Local Authorized Representative Required

Yes

Drug Approval Process

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.

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.

Decentralized Procedure

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. When the drug registration is taking place in the France then the type of the procedure used will be the national procedure.

Process to do Pharmaceutical Product Registration in Latvia

1.  Application for Marketing Authorization (MAA)

The pharmaceutical business or sponsor must submit a Marketing Authorization Application as the initial step. Comprehensive information about the medical product’s efficacy, safety, and quality is included in this application.

2. Assessment

The MAA is examined by the State Agency of Medicines to make sure all legal requirements are met. Preclinical and clinical data are assessed as part of the review process, which also encompasses an analysis of the manufacturing procedures used to produce the product.

3. Committees of Experts

The Latvian Medicines Commission is one example of an expert group that might be included in the evaluation process. These committees offer suggestions and counsel about the authorization of pharmaceuticals.

4. Decision

The State Agency of Medicines decides whether to authorize the medicinal product for marketing based on the evaluation. A marketing authorization is given out if it is accepted.

5. Post-Marketing Surveillance

Following a drug’s release onto the market, post-marketing monitoring keeps an eye on its efficacy and safety. Any adverse reactions or fresh facts on the safety of the product must be reported to the pharmaceutical company.

Registration Fee

  • 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.

Documents

  • Power of Attorney
  • Import License
  • European Drug Master File
  • Certificate of Suitability

Generic Drug Approval

1. Citation of the Concerned Member State (CMS) or Reference Member State (RMS)

For the application, generic medication companies usually select a Reference Member State (RMS). The review procedure must be coordinated by the RMS. When not requesting simultaneous marketing authorization in every EU member state, businesses may choose to apply to a Concerned Member State (CMS).

2. Application for Marketing Authorization (MAA)

A Marketing Authorization Application is sent by the generic medicine manufacturer to the selected RMS or CMS. Data proving the generic medication’s bioequivalence to the reference pharmaceutical product is included in the application.

3. Studies on Bioequivalence

In other words, generic medications need to show that they function therapeutically and absorb at the same rate as the reference medicinal product to be considered bioequivalent. Studies on bioequivalence are an essential component of the application process.

4. Regulatory Authorities Assessment

The quality, safety, efficacy, and bioequivalence data of the generic medicine are all considered by the regulatory bodies, which in Latvia include the State Agency of Medicines, while evaluating the MAA.

5. Mutual Recognition Procedure or Decentralized Procedure

The decentralized approach, also known as the mutual recognition procedure, may be used for generic medications approved in different EU member states. Under these protocols, the evaluation is headed by the RMS or CMS, and the decision is acknowledged by other member states.

6. Marketing Authorization Selection

The State Agency of Medicines decides whether to approve generic medication for marketing based on the evaluation.

License Validity

5 Years  

Registration Fee

2000.00 EUR

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