EXPORT OF MEDICINE TO OTHER COUNTRY

CERTIFICATE OF PHARMACEUTICAL PRODUCT 1
(This Certificate conforms to the format recommended by the World Health Organization)
Certificate No: _
Issued Date: Exporting Country: Pakistan
Importing Country: Vietnam
Proprietary name (if applicable) and dosage form:
Active Ingredient (s) and amount (s) per unit dose3: (Complete qualitative composition including excipient): See 1. Is this product licensed to be placed on the market for use in the exporting country?4 Yes / No (If Yes, complete Box A, if No Complete Box B)

A) Product License holder:
Medicraft Pharmaceuticals (PVT) LTD.
126-B Industrial Estate Hayatabad Peshawar, Pakistan.
Mfg. License No: 000390 Date: 26.06.2004

b) Status of the license holder5


c) Number of product license6 and date of issue: 000650EX Dated-13.03.2007

d) Is an approved technical summary appended?7 Yes / No
e) Is the attached product information complete and consonant with the license?

Yes No Not Provided

Application for certificate if different form the license holder. NA


B) Application for certificate: Not applicable

b) Status of the license holder5




2. a) Does the certifying authority arrange for periodic inspection of manufacturing plant in which the dosage form is produced?
Yes No (If no proceed to Question 3)
b) Periodicity of routine inspections (Years): 2 Times per Year. Yes No
c) Has the manufacturer of this type of dosage form been inspected. Yes No
d) Do the facilities and operations conform to GMP as recommended by the World Health Origanization?10 Yes No
3. Do the information submitted by the applicant satisfy the certifying authority on all aspects of the manufacturing of the products undertaken by another party?11

Yes No (If no, Explain)

Address of certifying authority: Name of authorized PersonDesignation:
Signature, Date & Stamp:

GENERAL INSTRUCTIONS

PLEASE REFER TO THE GUIDELINES FOR FURTHER INFORMATION ON HOW TO COMPLETE THIS FORM AND ON THE IMPLEMENTATION OF THE SCHEME.
Forms should be completed using a type writer to ensure legibility.
Across should be in squares as appropriate to indicate which option apply.
Additional sheets should be appended, as necessary, to accommodate remarks and explanations.

EXPLANATORY NOTES

1. This certificate, which is in format recommended by the WHO, establishes the status of the pharmaceutical product and of the applicant for the certificate in the exporting country, it is for a single product only since manufacturing arrangements and approved information for different dosage forms and different strengths can vary.
2. Use, whenever possible, international nonproprietary names (INN) OR National proprietary names.
3. A qualitative listing of other ingredients contained in dosage form should be appended.
4. When applicable append details, if any restriction applied to sale, distribution or administration of the product that is entered on the product license.
5. Specify whether the person responsible for placing the product on the market:
a) Manufacture the active ingredients and the finished dosage form,
b) Manufacture the finished dosage form,
c) Package and / or labels, a finished dosage form manufactured by an independent company, or
d) Is involved in none of the above:
6. Indicative, when applicable, if the license is provisional, pending technical review.
7. This refers to the documents, prepared by certain national regulatory authorities, the summaries the technical basis on which the product has been licensed.
8. In the circumstance, permission for issuance of the certificate is required from the product license holder.
9. Please indicate the reasons the application has provided for non requesting registration.
a) The product has been developed exclusively for the treatment of condition-particularly topical disease-non endemic in the country of export.
b) The product has been reformulated with a view to importing its stability under topical conditions.
c) The product has been reformulated to exclude excipients not approved for use in pharmaceutical products in the country of import.
d) The product has been reformulated to need a different maximum dosage limit for an active ingredient.
e) Any other reasons please specify.
10. The requirements for good practices in the manufacture and quality control of drugs referred to in the certificate are those adopted by the Twenty Eight World Health Assembly in its resolution WHA 27–65.
(See WHO Official Records No 226.1975, Part–1 Annexure 12). Proposal for the amendment of these requirements and included in the thirty second report of the WHO expert committee on specifications for pharmaceutical preparations. Recommendations specifically applicable to biological products have been formulated by the WHO expert committee on biological standardization (WHO Technical report series No. 822.1992, Annexure 1).
11. This section is to be completed when the product license holder or applicant conforms to status (c) or (d) as described in note 5 above. It is of particular importance when foreign contractors are involved in the manufacture of the product.
In these circumstance, the applicant should supply the certifying authority with information to identify the contracting parties responsible for each stage of manufacture of the finished dosage form and to indicate the extent and nature of any control exercised over each of these parties.