Наредба №27 от 15 юни 2007 г за изискванията към данните и документацията за разрешаване за употреба и регистрация на лекарствени продукти

ANNEXED DOCUMENTS (where appropriate)

Proof of payment

Informed consent letter of marketing authorisation holder of authorised medicinal product

Proof of establishment of the applicant in the EEA

Letter of authorisation for communication on behalf of the applicant/MAH

Curriculum Vitae of the Qualified Person for Pharmacovigilance

Manufacturing Authorisation required under Article 146 of LMPHM and Article 40 of Directive 2001/83/EC (or equivalent, outside of the EEA where MRA or other Community arrangements apply). A reference to EudraGMP will suffice when available.

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

Забележка. Имената, точните адреси и дейности на всички места за производство и контрол, упоменати където и да е в цялото досие, трябва да си съответстват.

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). Note: ALL manufacturing and control sites mentioned throughout the whole dossier MUST be consistent regarding their names, detailed addresses and activities.

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

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

Copy of written confirmation from the manufacturer of the active substance to inform the applicant in case of modification of the manufacturing process or specifications according to the Regulation according Article 42 of LMPHM and Annex I of Directive 2001/83/EC

Ph. Eur. Certificate(s) of suitability for TSE with declaration of access

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

Scientific Advice given by CHMP

Copy of Marketing Authorization(s) required under Article 27(1), p. 14-16 and 19-22 of LMPHM and Article 8(j)-(L) of Directive 2001/83/EC in the EEA and the equivalent in third countries

Correspondence with European Commission regarding multiple applications

List of Mock-ups and Samples/specimens sent with the application, as appropriate

Copy of the Orphan Designation Decision.

List of proposed (invented) names and marketing authorisation holders in the concerned member states

Copy of EMEA certificate for a Vaccine Antigen Master File (VAMF)

Copy of EMEA certificate for a Plasma Master File (PMF)

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

APPLICATION FORM FOR MARKETING AUTHORISATION/REGISTRATION OF HOMEOPATHIC MEDICINAL PRODUCT

РЕЗЮМЕ НА ДОСИЕТО

SUMMARY OF THE DOSSIER

ADMINISTRATIVE DATA

The application form is to be used for an application for a marketing authorisation of a medicinal product for human use submitted to the Bulgarian Drug Agency either a national, mutual recognition procedure or decentralised procedure.

За всяка лекарствена форма и количество на активното вещество в дозова единица, определена маса или обем се попълва отделно заявление. Комбинирано заявление е приемливо в случаите, предвидени в чл. 14, ал. 4 на наредбата по чл. 42 ЗЛПХМ (в такъв случай информацията в съответните раздели на заявлението трябва да бъде представена последователно за всяка лекарствена форма и количество активно вещество).

Usually a separate application form for each strength and pharmaceutical form is required.

А combined application form is acceptable only as provided Article 14(4) of the Regulation according Article 42 of Law of Medicinal Products for Human Medicine (LMPHM) (information on each pharmaceutical form and strength should be provided successively, where appropriate).

DECLARATION and SIGNATURE

Име (свободно избрано) на лекарствения продукт:

Product (invented) name:

На кирилица:

CyriLlic

Latin

Homeopathic stock(s) and potency(ies):

Заявител:

Applicant:

Упълномощено от заявителя лице за кореспонденция:

Person authorised for communication*, on behalf of the Applicant:

Тук потвърждавам, че всички налични данни, които се отнасят до качеството, безопасността и ефикасността на лекарствения продукт са представени в досието.

Тук потвърждавам, че всички данни са представени както на хартиен, така и на електронен носител и че информацията на двата вида носители е идентична.

Тук потвърждавам, че са платени всички такси по Тарифата по чл. 21, ал. 2 ЗЛПХМ**

It is hereby confirmed that all existing data which are relevant to the quality, safety and efficacy of the medicinal product have been supplied in the dossier, as appropriate.It is hereby confirmed that all data have been supplied both as hard copy as well as on electronic medium and the information on all kinds of media is identical.

It is hereby confirmed that fees have been paid according to the national rules

От името на заявителя

On behalf of the applicant

Signature(s)

______________________________________________________

ИМЕ*

_______________________________________________________

Длъжност/функция

Function

Населено място дата (гггг-мм-дд)

Place date (yyyy-mm-dd)

Note: please attach letter of authorisation for communication/signing on behalf of the applicant in annex 4.4

** Забележка: Като приложение 4.1 приложете документи за платени такси по Тарифата по чл. 21, ал. 2 ЗЛПХМ.

Note: if fees have been paid, attach proof of payment in Annex 4.1

___________________________________________________________________

TYPE OF APPLICATION

Забележка.Съответните точки на този раздел се попълват, когато е подходящо.

Note: The following sections should be completed where appropriate.

1.1. ЗАЯВЛЕНИЕТО Е ЗА:

This application concerns:

A mutual recognition procedure (according to Article 74 and 76(1) of LMPHM and Article 28(2) of Directive 2001/83/EC )

Reference Member State:

Date of authorisation: ( yyyy-mm-dd):

Marketing authorisation number:

(да се приложи копие от разрешението - вж. раздел 5.2)

(a copy of the authorisation should be provided - see section 5.2)

Procedure number:

First use

Concerned Member State(s) (specify):

Proposed Common Renewal Date:

Ако се кандидатства за отмяна или изменение в цикъла на подаване на периодични доклади за безопасност, с цел хармонизиране с рождената дата за веществото, моля, посочете:

If a waiver or amendment of PSUR-cycle is applied for, to harmonise with a substance birthdate, please specify:

○ Повторно използване 1ва вълна (попълнете и раздел 5.2)

Repeat Use 1st Wave (please also complete section 5.2)

■ Засегната държава членка(и) (отбележете):

Concerned Member State(s) (specify):

За следващи процедури копирайте таблицата по-горе

For subsequent procedures copy the boxes above