Application form for TAIEX Workshop
Please note: TAIEX can undertake the majority of the arrangements and costs for its workshops. However please note that in making this request for a workshop the following support must be provided by your country: 1. Submission of draft law, laws or policy statements, and/or relevant documentation or a short written summary of the current situation regarding the sector.
2. Liaison with participants regarding the event and submission of a complete list of participants (with their job title, full contact details & name of administration), no later than 21 calendar days before the event. 3. When appropriate, assistance to TAIEX representatives, chairperson and experts/speakers during the event. 4. Submission of a short evaluation report of the event.
Beneficiary country: Beneficiary Ministry/Service
Date of submission:
Turkey The Turkish Ministry Of Health/ Directorate General of Pharmaceuticals and Pharmacy 10/10/2008
1. Person submitting the application:
Title1: First Name: Surname: Ministry or Institution: Mrs. Canan Kutsal The Turkish Ministry Of Health/ Directorate General of Pharmaceuticals and Pharmacy Department: Function: Office address (street/number/office number): Biological Products Department Manager Çankırı Caddesi No:57 Dışkapı/ULUS
Post code: City: Office Tel: Office Fax: E-mail:
06060 Ankara +903123091141-1142 +903123097118 canan.kutsal@iegm.gov.tr
1
Personal data contained in this document will be processed in accordance with the privacy statement of the TAIEX instrument (See http://taiex.ec.europa.eu/privacystatement) and in compliance with the Regulation (EC) N° 45/2001. Rue de la Loi 200, B-1049 Bruxelles/Wetstraat 200, B-1049 Brussel - Belgium - Office: CHAR 03/149 Telephone: switchboard +32-2-296 73 07, 296 73 08, Fax: +32-2-296 76 94 Page 1 of 5
2. Workshop content:
Proposed title of the workshop The Application and Registration Process For Allergenic Products Proposed date (indicative) Expected number of participants: Target audience: (specify if Ministries, institutions, regulatory authorities, professional associations or other) 4. week of 2009 50 The Turkish Ministry Of Health/ Directorate General of Pharmaceuticals and Pharmacy
3. EU Legislation (acquis communautaire) for this event:
Sector of EU legislation
CELEX N°/Natural number: Type of legislation: 32001L0083 / 2001/83/EC and 32003L0063 / 2003/63/EC Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use; Commission Directive 2003/63/EC of 25 June 2003 amending Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use Screening chapter: Free Movement Of Goods
Main topic/content
Agenda: Indicate specific items which should be included on the agenda and/or attach draft programme, if available The information in the valid guidelines about the applications and the assessments of the dossiers of allegenic products (esp. patch test, name patient products) is deficient in our country. The answers of questions below should be included on the agenda: - Can all allergenic products (esp. patch test and name patient products) be evaluated within the scope of directive 2001/83/EC, or can not? -If yes; how is the registration process for these allergenic products (esp. patch test and name patient products)? -If no; how is the registration process for these allergenic products? And what are the points that should be evaluated carefully while evaluating the whole dossier ( esp. Module 3, SmPC and PL)? -How is the course while pricing all allergenic products ? -How is the course while the allergenic products are obtained for patient?
4. Current situation:
Rue de la Loi 200, B-1049 Bruxelles/Wetstraat 200, B-1049 Brussel - Belgium - Office: CHAR 03/149 Telephone: switchboard +32-2-296 73 07, 296 73 08, Fax: +32-2-296 76 94 Page 2 of 5
Please describe briefly your current situation concerning the sector of the acquis communautaire indicated above and explain why the workshop is necessary now: Harmonization of the published directives (2001/83/EC and 2003/63/EC) for EU registration process is concluded in our country. By this way, Human medicine registration guideline become valid in our country with being published in gazette numbered 25705 on the date of 19.01.2005. The application dossiers and registration process of all human medicines are evaluated within the scope of this guideline. But in this guideline, there is no special information about the application and evaluation of all allergenic products (esp. patch test and name patient products). So in our country we have some difficulties about the registration process of these products. For this reason, with the aim of directing us about the applications and evaluations of allergenic products which have to be registrated after the published date of human medicine guideline in our country, we are demanding a workshop that will be presented by related experts esp. from Germany, France or Spain.
Rue de la Loi 200, B-1049 Bruxelles/Wetstraat 200, B-1049 Brussel - Belgium - Office: CHAR 03/149 Telephone: switchboard +32-2-296 73 07, 296 73 08, Fax: +32-2-296 76 94 Page 3 of 5
LOGISTICAL ASPECTS – WORKSHOP DETAILS
Contact person for administrative questions and practical matters related to this event
Title2: First Name: Surname: Ministry or Institution: Department: Function: Office address (street/number/office number): Mrs. F. Handan Oztunca The Turkish Ministry Of Health / Directorate General of Pharmaceuticals and Pharmacy Biological Products Pharmacist Çankırı Caddesi No:57 Dışkapı / ULUS
Post code: City: Office Tel: Office Fax: E-mail:
06060 Ankara +903123091141-1142 +903123098769 fhandan.oztunca@iegm.gov.tr
Is accommodation required? (applies only to journey of 100km and above) Is interpretation required? If yes, between which languages? Does your administration have suitable conference facilities available? If yes, are these facilities free of charge?
Yes Yes
Between
No No
English and Turkish
Yes Yes
No No
Conference venue address: (street, number, office number)
The Turkish Ministry Of Health Refik Saydam Hygiene Center's Assembly Room Cemal Gursel Caddesi No:18 Sihhiye
Post code: City: Office Tel.:
06100 Ankara +903124580000
2
Data received from you is to be used for the organisation of TAIEX events only, and for no other purpose unless stated. You are entitled to have your data deleted or removed from our database at any time.
Rue de la Loi 200, B-1049 Bruxelles/Wetstraat 200, B-1049 Brussel - Belgium - Office: CHAR 03/149 Telephone: switchboard +32-2-296 73 07, 296 73 08, Fax: +32-2-296 76 94 Page 4 of 5
Office Fax.: E-mail:
+903124582408
Please complete and return to: European Commission, Institution Building unit (TAIEX) Rue de la Loi 200, B-1049 Brussels Fax: +32-2-296 76 94 E-mail: Elarg-Taiex@ec.europa.eu
Please note: The information contained in this form will be made available on-line to the Permanent Representation, or Mission of your country in Brussels. All applications received directly from the Western Balkans' administrations will be forwarded to the EU Delegation in the country concerned, and in the case of Kosovo to the EC-Liaison Office, for a preliminary evaluation.
Rue de la Loi 200, B-1049 Bruxelles/Wetstraat 200, B-1049 Brussel - Belgium - Office: CHAR 03/149 Telephone: switchboard +32-2-296 73 07, 296 73 08, Fax: +32-2-296 76 94 Page 5 of 5