Pakistan Drug Product Registration

Sr

Form 5

Procedure to be adopted

1.       

Name and address of the manufacturer (applicant)

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2.       

Brand name of Drug

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3.       

The chemical name(s) and, as appropriate and available the established (generic) names and synonyms of the drug.

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4.       

Strength of active ingredient(s) per unit, e.g. each tablet or 5 ml, etc. contains

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5.       

Pharmacological group.

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6.       

Recommended clinical use.

·        Commitment to follow innovator brand or as approved by any reference regulatory authority (as approved in 249^th meeting) and only such information shall be mentioned in medical literature/ patient information leaflet.

·        This condition shall also be mentioned in registration letter.  

7.       

Proposed route of administration.

·        Commitment to follow innovator brand or as approved by any reference regulatory authority (as approved in 249^th meeting) and only such information shall be mentioned in medical literature/ patient information leaflet.

·        This condition shall also be mentioned in the registration letter.  

8.       

Proposed dosage.

·        Commitment to follow innovator brand or as approved by any reference regulatory authority (as approved in 249^th meeting) and only such information shall be mentioned in medical literature/ patient information leaflet.

·        This condition shall also be mentioned in registration letter.  

9.       

Proposed shelf life of the drug

As per commitment (max 2 years). 

10.    

Proposed storage conditions of finished product.

·        Commitment to follow innovator brand or as approved by any reference regulatory authority (as approved in 249^th meeting) and only such information shall be mentioned in medical literature/ patient information leaflet.

·        This condition shall also be mentioned in registration letter.  

11.    

Unit price of the drug, e.g. per tablet, per capsule, per 5ml, etc.

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12.    

In case of international availability, provide the following information, namely:- a. name of the drug; b. country where sold / registered; and c. name of company selling the drug or having registration to manufacture (include supporting documents/proof of International registration.

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13.    

Brand name(s) of drug available in Pakistan.

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14.    

Name(s) of company(s) manufacturing in Pakistan.

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15.    

Composition (actives & excipients) including statement of the quantitative composition, giving the weight or measure for each active substance used in the manufacture of the dosage form.

Commitment for following:

·        Pharmaceutical product development (before sale of drug) in line with the composition of innovator or any other generic approved by any reference regulatory authority. For excipients, equivalent alternates can be used.

·        No banned excipient shall be used. All excipients are required to be of pharmaceutical grade and within safe limits.

16.    

Outline of method of manufacture.

Flow chart is required

17.    

Persons under whose direct supervision and control the drug is manufactured with the following details, namely:- a. total number of technical staff; and b. name, qualification and designation of the persons directly supervising the manufacture of the drug applied for registration, and any change shall be properly documented and record maintained by the manufacturer.

As per information provided by the firm

18.    

Name of equipment that will be used in the manufacture of the drug applied for registration

As per information provided by the firm according to the applied dosage form of the drug

19.    

Full descriptions of the specifications and analytical methods necessary to assure the identity, strength, quality, purity and homogeneity throughout the shelf life of the drug product.

Commitment for complying Drug Specification Rules, 1978 and validation of analytical methods (before sale of drug) to assure the identity, strength, quality, purity and homogeneity throughout the shelf life of the drug product.