Modalità di presentazione delle domande di nuova AIC

Ref:

Name of Document and Template

Notes

6.1

Proof of payment

In original with the product name and full procedure number clearly specified

6.2

Informed consent letter

6.3

Proof of establishment of the company in the EEA

6.4

Letter of authorisation for communication on behalf of the Applicant

6.5

Curriculum Vitae of the Qualified Person for Pharmacovigilance

6.6

Manufacturing Authorisation required under Article 40 of Directive 2001/83/EC (or equivalent, outside of the EEA where MRA or other Community arrangements apply) for all the manufacturing sites. A reference to EudraGMP will suffice when available.

The Manufacturing Authorisation(s) issued in a language other than English, should be accompanied by English/Italian translation(s).

6.7

Justification for more than one manufacturer responsible for batch release in the EU/EEA

6.8

Flow-chart indicating all sites involved in the manufacturing process of the medicinal product or active substance (including sites involved in sampling and testing for batch release of products manufactured in third countries).

6.9

Statement (or GMP Certificate issued by an EEA inspectorate, when available) from the competent authority which carried out the inspection of the manufacturing site(s) (not older than 3 years). References to EudraGMP will suffice when available. Where applicable a summary of other GMP inspections performed in the last 2 years

The relevant document(s) issued in the Member States languages if not in English, should be accompanied by English/Italian translation(s).

6.10

Letter(s) of access to Active Substance Master File(s) or copy of Ph. Eur. Certificate(s) of suitability

6.11

Copy of written confirmation from the manufacturer of the active substance to inform the applicant in case of modification of the manufacturing process or specification according to Annex I to Directive 2001/83 EEC

6.12

Ph. Eur. Certificate(s) of Suitability for TSE

6.13

Written consent(s) of the competent authorities regarding GMO release in the environment

6.14

Scientific advice given by CHMP

6.15

Copy of the Marketing Authorisation(s) issued by the Competent Authority in the EEA and the equivalent in third countries on request

The Marketing Authorisation(s) issued in the Member States languages if not in English, should be accompanied by English/Italian translation(s).

6.16

Correspondence with European Commission regarding multiple applications

6.17

List of Mock-ups or Samples/specimens sent with the application, as appropriate (See NtA, Volume 2A, Chapter 7)

A copy of the proposed Mock-ups in English should be submitted.

6.18

Copy of the Orphan Designation Decision

6.19

List of proposed (invented) names and MA holders in the CMS(s)

6.20

Copy of EMEA certificate for vaccine antigen master file (VAMF)

6.21

Copy of EMEA certificate for plasma master file (PMF)

6.22

For each active substance, attach a declaration from the Qualified Person of the manufacturing authorisation holder in Section 2.5.1 of the Application Form and from the Qualified Person of each of the manufacturing authorisation holders (i.e. located in EEA) listed in Section 2.5.2 of the Application Form where the active substance is used as a starting material that the active substance manufacturer(s) referred to in Section 2.5.3 of the Application Form operate in compliance with the detailed guidelines on good manufacturing practice for starting materials. This does not apply to Blood or blood components.

Cover Letter per la presentazione di una domanda

In originale.

La lettera, corredata da marca da bollo, deve chiaramente indicare il nome del medicinale e il numero di procedura, specificando in dettaglio la documentazione allegata.

Certificato GMP

Richiesto solo se l’ Assessment Report non contiene la dichiarazione da parte del RMS sullo stato GMP di tutte le officine (come concordato in sede MRFG).

E’ richiesto l’invio di fotocopia se il certificato è incluso nel Modulo 1.

E’ richiesta traduzione in Inglese.

Dichiarazione di identicità

In originale.

Documento richiesto solo se una equivalente dichiarazione non è presente nella Cover Letter; la Cover Letter deve essere firmata dal Titolare dell’autorizzazione all’immissione in commercio nell’RMS, nel caso di Procedure di Mutuo Riconoscimento, o dal Richiedente nell’RMS, nel caso di Procedura decentrata.

Dichiarazione sui Moduli 4 e 5

In originale.

La dichiarazione è richiesta solamente per i Moduli 4 and 5 in formato cartaceo e qualora non contenuta nella Cover Letter.

Moduli da 1 a 5

E’ richiesta una versione elettronica su CD Rom dell’intero dossier.

Dichiarazione relativa ai Campioni

In originale.

Documento richiesto solo se una equivalente dichiarazione non è presente nella Cover Letter