NEW LICENCE REQUEST FORM – WHOLESALER by olliegoblue35

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									  APPLICATION FORM FOR A NEW AUTHORISATION/LICENCE - MANUFACTURER

Section 1 - Applicant Details
Name of proposed authorisation/licence holder

Legally registered address of proposed
authorisation/licence holder

Trading style (if applicable)

Address of manufacturing site


Companies office registration number

Name and address of applicant (if different
from the proposed authorisation/licence holder)

Telephone / fax number of applicant

E-mail address of applicant


Section 2 – Type of Authorisation/Licence *(please tick)
Manufacturer of Medicinal Products for human use (Medicinal Products (Control of
Manufacture) Regulations 2007)
Manufacturer of Medicinal Products for veterinary use (European Communities (Animal
Remedies) Regulations 2007
Manufacturer of Investigational Medicinal Products (Medicinal Products (Control of
Manufacture) Regulations 2007)
* A separate application is required for each type of Authorisation / Licence sought


Section 3 – Definition of Operations
Operation                                 Tick Operation                                          Tick
Manufacture of medicinal products                 Site of Importation of products from
(including Partial Manufacture)                   outside EEA
Primary Packaging                                 Distribution (to market)
Secondary Packaging                               Batch release of imported products
Testing (in-process and Finished Product          Blinding (ref: Glossary in Annex 13 of EC Guide
testing)                                          to GMP)
Batch Release                                     *Importation of exempt Medicinal
(final Qualified Person certification of          Products
Finished Product)
Storage                                           Other:
*As defined in Schedule 1 of Medicinal Products (Control of Manufacture) Regulations 2007.

Section 4 – Draft Authorisation/Licence
The applicant must submit a draft version of the authorisation/licence they wish to apply for. Please
email compliance@imb.ie to request a blank draft authorisation/licence.


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Section 5 – Importation from outside the EEA
The applicant must submit details relating to each Medicinal Product imported from outside the
European Economic Area (EEA), if applicable.
- Product Category
- Active Ingredient name
- Strength
- Dosage form
If the application relates to Investigational Medicinal Products please submit details relating to the
product category and dosage form only.

Section 6 - Personnel
Curriculum Vitae, abbreviation of qualifications and Training Records should be submitted for the
following personnel:
- Qualified Person(s) (Please specify primary or deputy, if applicable)
- Person(s) responsible for Production Operations
- Person(s) responsible for Quality Control
- Person(s) responsible for Biological Testing

Section 7 - Contract Manufacturers
The applicant must submit the following details relating to contract manufacturing facilities used:
    - Name and address of facility (including building numbers, if applicable)
    - Manufacturing operations performed (refer to Section 3)
    - Product category

The applicant must also submit evidence of satisfactory inspection within the previous 3 years for
each contract manufacturing facility by an EEA Competent Authority or MRA Partner.
    - Date of last inspection
    - Scope of last inspection
    - Statement from inspecting authority regarding compliance of the facility in relation to the
       areas covered by the inspection.

Section 8 - Contract Laboratories
The applicant must submit the following details relating to contact laboratories used for finished
product testing and/or used for stability testing:
    - Name and address of facility (including building numbers, if applicable)
    - Indicate testing performed – Physical/Chemical/Microbiological/Biological

The applicant must also submit evidence of satisfactory inspection within the previous 3 years for
each contract laboratory by an EEA Competent Authority or MRA Partner.
    - Date of last inspection
    - Scope of last inspection
    - Statement from inspecting authority regarding compliance of the facility in relation to the
       areas covered by the inspection.

Section 9 – Recall Procedure
The applicant must submit a copy of the company’s Recall Procedure in accordance with Paragraph
13 of Schedule 2 of the Medicinal Products (Control of Manufacture) Regulations 2007 (S.I. No 539
of 2007) and Paragraph 10 (d) of Schedule 1 of the Medicinal Products (Control of Manufacture)
Regulations 2007 (SI No 539 of 2007) and Paragraph 12 of Schedule 5 of the European Communities
(Animal Remedies) Regulations 2007.
Explanatory notes on the preparation of a Recall Procedure can be found on www.imb.ie –
compliance/publications/industry guides.




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Section 10 – Site Master File
The applicant must submit a copy of the facility’s Site Master File in accordance with Pharmaceutical
Inspection Co-Operation Scheme (PIC/s). Explanatory Notes on the preparation of a Site Master File
can be found on www.picscheme.org - Document PE008-2 October 2004

Section 11 – Fees / Classification of facility (Please tick)

Major Site              Large site                    Medium site                Small Site
(›250 employees)        (150-250 employees)           (50-149 employees)         (<50 employees)

The applicant must submit an application fee with each request for a new manufacturer’s
authorisation/licence. An annual maintenance fee is also payable in respect of each
authorisation/licence and is related to the size of the facility based on the numbers of relevant
employees.
Please refer to the IMB Guide to Fees on www.imb.ie human medicines/publications/fees & dossier
submission and/or veterinary medicines/ publications/ fees & dossier submission and complete the fee
application form.

Section 12 - Checklist
The following information must be submitted with the application (except where not applicable):

 1    Letter of application
 2    Completed application form
 3    Certificate of Incorporation
 4    Draft version of Manufactures Authorisation/Licence
 5    List of products (API, form and strength) imported from outside the EEA
 6    Details (name, address and operation) of contract manufacturing sites
 7    Details (name, address and operation) of contract laboratories
 8    Details relating to proposed Qualified Person(s)
 9    Details relating to proposed Person(s) responsible for Quality Control
 10   Details relating to proposed Person(s) responsible for Production Operations
 11   Details relating to proposed Person(s) responsible for Biological Testing
 12   Recall Procedure
 13   Site Master File
 14   Classification of facility (Major / Large / Medium / Small) site
 12   Fee application form
 13   Relevant fee (application charge)
 14   Signed Declaration as referred to in regulation 6(2)(b) of Control of Manufacture
      Regulations 2007 (see section 13).

Section 13 - Declaration
Regulation 6(2)(b): In the event of the authorisation/licence being granted, the applicant undertakes
to ensure fulfilment of the obligations arising by virtue of the terms and conditions of the
authorisation/licence and declares that the above particulars are, to the best of my knowledge and
belief, correct on behalf of the Authorisation/Licence.


Signature:                                                Date:




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SECTION 14 - OFFICIAL USE ONLY


DRAFT AUTHORISATION /LICENCE NUMBER
IMB INTERNAL REF NUMBER
RECALL PROCEDURE PASSED MARKET
COMPLIANCE:                             DATE:
ACKNOWLEDGEMENT SENT BY:                DATE:
DRAFT PREPARED BY:                      DATE:


                                        SIGN AND DATE
INSPECTOR’S RECOMMENDATION
   1. AUTHORISATION GRANTED IN ACCORDANCE WITH APPLICATION
   2. AUTHORISATION GRANTED SUBJECT TO CARRYING OUT CERTAIN OBLIGATIONS
   3. AUTHORISATION GRANTED OTHERWISE THAT IN ACCORDANCE WITH APPLICATION
   4. PROPOSAL TO REFUSE THE AUTHORISATION


                                        SIGN AND DATE
RECOMMENDED TO MANAGEMENT
COMMITTEE

DECISION OF MANAGEMENT COMMITTEE:


DATE OF MEETING:                       TICK BOX WHERE APPROPRIATE        √
  1. AUTHORISATION GRANTED IN ACCORDANCE WITH THE APPLICATION
  2. AUTHORISATION GRANTED SUBJECT TO CARRYING OUT CERTAIN OBLIGATIONS
  3. AUTHORISATION GRANTED OTHERWISE THAT IN ACCORDANCE WITH APPLICATION
  4. PROPOSAL TO REFUSE THE AUTHORISATION


                                        INITIALS & DATE
FINAL AUTHORISATION/LICENCE PREPARED
BY
FINAL AUTHORISATION/LICENCE APPROVED
BY
EXCEL DATABASE UPDATED
COMPLIANCE DATABASE UPDATED
UPDATE LIST OF AUTHORISED WHOLESALERS
ON WEBSITE
POSTED




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