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Pharmaceutical/Medicine/Drug/OTC Registration in Portugal

Pharmaceutical /Medicine/Drug/OTC registration in Portugal

MOH-Ministry of Health

MOH website- https://www.portugal.gov.pt/

Regulatory Authority-Infarmed

Regulatory Authority Website- https://www.infarmed.pt/

Local Authorized Representative Required –Yes

Drug Approval Process

  • National Procedure-

The national procedure (NP) authorizes medications that are not covered by the centralized procedure or those were approved prior to the EMA’s formation. Manufacturers who want to get market authorization in particular 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 are permitted to sell their products to healthcare professionals through a centralized mechanism that comes 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.

  New Drug Approval Process

1.Submission of Applications:

The pharmaceutical business or sponsor files a marketing authorization application with Infarmed. The application contains thorough data on the drug’s quality, safety, and efficacy.

  1. Validation:

 Infarmed evaluates the submitted application to ensure that it is comprehensive and fits the standards. If the application is incomplete, the applicant may be requested to give additional information.

  1. Evaluation:

Experts undertake scientific evaluations to determine the drug’s quality, safety, and efficacy. The examination may involve multiple committees and experts, who may request additional information or explanation from the applicant.

  1. Decision Making:

Based on the evaluation, Infarmed decides whether to approve, deny, or conditionally approve the medicine.If accepted, marketing authorization is provided. 

  1. Post-marketing surveillance:

Following licensure, the drug’s safety and efficacy are continuously monitored.

Any unpleasant reactions or safety concerns should be communicated to Infarmed.

Documents

1.SPC

2.Declaration of compliance of national translations of the product information

3.Labelling leaflet

4.Quality Documents

5.Nonclinical Documents

6.Clinical Documents

 Documents For MRP and DCP 

Module 1: Regional Administrative information

  • Module 1.2. Application form The applicant should answer questions, if any, on the application form (administrative data, samples, information on manufacturing sites and marketing authorisations).
  • Module 1.3.1 Summary of Product Characteristics, Package Leaflet and Labelling This part should include the new proposed SmPC/PL and Labelling including relevant tabular format with the answer to the questions raised by the Member States on the different sections of the SmPC/PL and the Labelling.
  • Module 1.3.4: User consultation
  • Module 1.7 Information relating to orphan market exclusivity
  • Module 1.8.1: Change of future MAH and sPhVS1

Module 2: Common Technical Document Summaries

Module 2.3 – Quality Overall summary

Module 2.6 – Nonclinical Written summaries

Module 2.7- Clinical Written Summaries

Module 3: Quality

The applicant should answer questions, if any, on chemical, pharmaceutical and biological documentation. Updated sub-sections of Module 3 must be provided.

Module 4: Nonclinical study reports

The applicant should answer questions, if any, on toxic-pharmacological documentation.

Module 5: Clinical study reports

The applicant should answer questions, if any, on clinical documentation

Approval Process of Generic Drug

  1. Referral to Reference Medicinal Product

Generic medicine applications often refer to a previously authorized reference medical product (originator or reference drug) approved in the EU.

  1. Marketing Authorisation Application (MAA) Submission

The pharmaceutical business or sponsor submits a Marketing Authorization Application to the European Medicines Agency (EMA) or a national regulatory authority, depending on the chosen regulatory pathway.

  1. Review & Evaluation

The EMA or national regulatory authority undertakes a thorough examination of the generic drug’s documentation, which includes information about the drug’s quality, safety, and effectiveness. The screening procedure includes expert assessments, and the applicant may be asked for additional information.

  1. Bioequivalence Studies

Generic drug applicants are usually required to do bioequivalence studies to show that their product is pharmaceutically and bioequivalent to the reference medicinal product. Bioequivalence studies compare the pharmacokinetic parameters of the generic medicine with those of the reference product.

5.Approval Phase

Based on the examination, the regulatory body decides whether to give marketing authorization for the generic medication.If approved, the generic medication is authorized for marketing and a marketing authorization is granted.

6.Post-marketing surveillance

Following approval, the safety and efficacy of the generic medicine are continuously monitored. Adverse reactions or safety concerns should be reported to appropriate regulatory authorities.

Documents for ANDA Submission

1.Administrative Documents

2.Quality Documents

3.Bioequilivence Study Reports

4.GMP Certificate

Labelling- In Portugues