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Romania Drug Product Registration

Romania Drug Product Registration

MOH

Ministry of Health

MOH Website 

https://www.ms.ro/en/ 

Regulatory Authority 

National Agency for Medicines and Medical Devices of Romania

Regulatory Website 

https://www.anm.ro/ 

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.

The Decentralized Procedure is divided in six steps:

  • Pre-procedural steps
  • Validation phase
  • Assessment step I
  • Assessment step II
  • Discussion at the CMDB, if needed
  • National step 

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.

Documents Required for Romania Drug Product Registration

  1.Power of Attorney

 2.Import License

 3.European Drug Master File

 4.Certificate of Suitability                                                   

Generic Drug Approval 

Application Submission

The pharmaceutical business that wants to sell a generic medication in Romania applies to the NAMMD. Comprehensive information about the drug’s effectiveness, safety, and quality is included in the application, along with proof that it is bioequivalent to the reference (originator) medication.

Review and Evaluation 

To make sure the generic medication satisfies the necessary requirements for quality, safety, and efficacy, the NAMMD examines the data that has been presented. Experts from the regulatory body conduct a thorough scientific review as part of this evaluation procedure.

Bioequivalence studies

Are essential to the approval of generic drugs. These studies show that, when given at the same dose, the generic and reference drugs produce comparable bloodstream concentrations of the active component.

Approval Decision 

The NAMMD decides whether to approve the generic medication following a careful examination and assessment. The medicine will be authorized for commercialization if it satisfies all regulatory standards, including bioequivalence.

Post-Marketing Surveillance

The NAMMD uses post-marketing surveillance to keep an eye on the efficacy and safety of generic medications even after they are approved. To guarantee continued safety and quality, this entails gathering and evaluating data on adverse responses and other pertinent information.

Orphan Drug

Orphan drugs are defined as pharmaceuticals “used for the treatment, prevention or diagnosis of conditions that affect up to five in 10,000 people (about the seating capacity of Cameron basketball stadium at Duke University) in the EU or that are life-threatening, chronically debilitating or represent serious and chronic conditions of the body” in Annex No. 1 to Ministry of Health Order No. 861/2014. 

Furthermore, no adequate technique of diagnosis, prevention, or treatment for these diseases has been approved by the EU; if one does, the medical product is very beneficial to the patients.

Romania identifies orphan medical products in accordance with Regulations 141/2000/EC and 847/2000/EC, and it also abides by the designation granted by the European Agency’s Committee for Orphan medical Products for the Evaluation of Medicinal Products in Article 3. 

Free Sale Certificate Required

Yes

License Validity

5 years

Registration Fee

20,000 euro