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Pharmaceutical Product Registration in Italy

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Pharmaceutical Product Registration in Italy

Pharmaceutical Product Registration in Italy

MOH – European Centre for disease control and Prevention

MOH Website 

https://www.salute.gov.it/

Regulatory Authority

Italian Medicines Agency (AIFA)

Regulatory Authority Website 

https://www.aifa.gov.it/

Local Authorized Representative Required

Yes

The authorization procedures provided by European law are:

  • 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.
  • 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.
  • 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.          

Centralized Authorization Procedure

Pharmaceutical businesses use the centralized authorization procedure, submitting a single marketing authorization application to EMA. The marketing authorization holder can promote and distribute the medicine to patients and healthcare professionals across the EU with a single authorization.

  • Submission of eligibility request

18 to 7 months before submission of marketing authorization application   (MAA).

  • Notification of intention to submit an application

7 months before submission of MAA

  • Appointment of rapporteurs

7 months before submission of MAA

  • Pre-submission meetings

6 to 7 months before submission of MAA

  • Re-confirmation of communicated submission date

2-3 months before submission of MAA

  • Submission and validation of the application

Submission of the dossier in eCTD format

  • Scientific evaluation

Up to 210 active days of assessment

  • European Commission decision

Within 67 days of receipt of CHMP opinion

Mutual Recognition Procedure

The MRP requires that the assessment and marketing authorization of one Member State (“Reference Member State (RMS)”) be “mutually recognized” by other “Concerned Member States (CMS).” The “repeat use” approach involves extending current marketing authorizations to other countries. 

The pharmaceutical business sends their application to the designated country for review, which may approve or reject it. The other countries must decide within 90 days whether to approve or reject the decision made by the original country (RMS). If a member state cannot approve the assessment report, summary of product characteristics, labeling, or package leaflet due to potential health or environmental risks, the relevant Co-ordination Group should issue a pre-referral procedure.

If the Member State(s) cannot reach an agreement within the 60-day pre-referral period, they can submit the case to the CHMP/CVMP for arbitration through the EMEA secretariat.

Decentralized Procedure

This applies in circumstances where no authorization exists in any EU Member State.  Identical dossiers are filed throughout all Member States seeking marketing authorization. The applicant will select a Reference Member State to draft assessment documents, which will then be sent to the Concerned Member States. 

They will either approve the evaluation or move the application to arbitration. The new Decentralized Procedure incorporates Concerned Member States earlier in the evaluation process than the MRP, reducing conflicts and facilitating marketing authorization applications in multiple markets.

The applicant can request approval of a draft assessment report, summary of product characteristics, labeling, and packaging leaflet proposed by a reference Member State within 210 days.

National Procedure 

The AIC issued under national procedure is only valid in Italy. AIFA verifies the compliance of the documentation submitted by the company and ensures that the medicine is produced in accordance with good manufacturing practices, that its components (active ingredient and other constituents) are appropriate, and that the manufacturer’s control methods are satisfactory.

AIFA, with the support of the Scientific Technical Commission (CTS) and the Higher Institute of Health (ISS), evaluates the data presented by pharmaceutical companies on chemical pharmaceutical, biological, drug-toxicology, and clinical on each drug intended for the Italian market to ensure its safety and efficacy requirements.

Generic Approval Process

Article 10(1) of Directive 2001/83/EC exempts applicants from providing pre-clinical test and clinical trial results if they can demonstrate that the medicinal product is a generic version of a reference product that has been authorized for at least 8 years in a Member State or the Community. A generic medicinal product is one that has the same active substance composition, pharmaceutical form, and bioequivalence as the reference product, as demonstrated by appropriate studies. 

Orphan Drugs

10 Years Market Exclusivity

Paediatric Exclusivity

Six-month extension to the product’s SPC

Data exclusivity

08 years.

Period during which a Company cannot cross-reference the data in support of another marketing authorization, i.e., generics, hybrids, and biosimilars cannot be validated by the Agency.

Registration Fee

For Human Medicine €291,800

For Veterinary Medicine – €146,100

License Validity

5 years

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