FarmavitaR+

Dossier

CTD

RO

Module 1.1

RO/EN

Part IA - Format

Module 1.2

RO/EN

Part IB - SPC

Module 1.3.1

RO/EN¹⁵

Part IB – Leaflets & Labels

Module 1.3.2 – 1.3.4

RO/EN¹⁶

Module 1.4

RO/EN

Module 1.5

RO/EN

Module 1 - Annex

RO/EN

Part IC – Expert Reports

Module 2

RO/EN

Part II

Module 3

RO/EN¹⁷

Part III

Module 4

RO/EN

Part IV

Module 5

RO/EN

Written responses

RO/EN

Variations

Application form

Type I Documentation

RO/EN

Type II Documentation

RO/EN

Written responses

RO/EN

Renewal

RO/EN

NtA vol. 2.B (Edition 1998)

CTD (Modules)

RO

Full dossier

Full dossier

1⁷²

Additional

Module 1.1

-

Additional Part IA

Module 1.2

2

Additional: IB, SPC, Leaflet, etc.

Module 1.3.1

Module 1.3.2

Module 1.3.3

2

Module 1.3.4

1

Module 1.3.5

3

Additional: IC Expert Reports

Module 1.4

-

Module 1.5

-

Module 1 - Annex

-

Module 2

1

Additional: Part II

Module 3

3

Additional: Part II for Biological/Biotech.

Module 3 for Biological/Biotech.

-

Additional: Part III

Module 4

1

Additional: Part IV

Module 5

-

Written responses

2⁷³

Variations

Application form

2

Type I Documentation

1⁷⁴

Type II Documentation

1⁷⁴

Supplementary info

-

Additional SPC/Leaflet

-

Additional Labels

-

Additional statement on Qualitative & quantitative Composition

-

Written responses

2⁷³

Additional DATA requested (1)

RO

Statement of compliance with GMP

X¹³

Statement for the MA transfer to local subsidiary

-

A certified copy of the marketing authorisation granted by the RMS

X¹³

Contract between marketing authorisation holder ant responsible of batch release/manufacturer/importer

X¹³

Application form signed by the MAH of the first authorisation

-

Legalised statement of acceptance to manufacture, control, … on behalf of MAH signed by QP (authentification of signature and of powers to act as the QP)

-

Method of manufacture

-

Drug substance specification

-

Finished product specification

-

GMP certificate (requested only if the GMP statement is not included in the A.R.)

X¹⁴

The person responsible for placing the medicinal product on the market in France (so called “exploitant” in french) should be specified, knowing that this “exploitant” should be a pharmaceutical site

-

Certificate of analysis (active/non active substance, etc.)

X

EDQM TSE certificate of suitability in case of company renewal application

X

TSE-tables

X¹³

Pharmacovigilance Responsible in National Territory

X¹³

The person responsible for placing the medicinal product on the market in Portugal, so called “Director Technico/Qualified Person” should be specified and his pharmaceutical site

-

Renewal

RO

European renewal application form

2

PSUR, incorporating compiled data on 5 years (4.5 years for the first renewal)

1²⁵

Clinical expert report/statement that addresses the current risk/benefit of the product

1²⁶

Current mutually recognised SPC

1²⁷

Proposed SPC

1²⁸

Commitment to take account of new studies considered necessary by the expert through the variation procedure after the renewal process is complete

1

Copy of an updated statement of compliance with the GMP from the competent authority (not older than 3 years)

1

PIL and label text relevant to each member state, for national approval only

2²⁸

Payment of the national fee

YES²⁹

Number of samples

RO

Finished medicinal product

H

All active substances

-

Non-pharmacopoeial active substance

-

Non-active substances

-