Schedule - A : The Drugs (Licensing, Registring and Advertising) Rules, 1976

SCHEDULE A[See rule 2 (e)] Form 1[See rule 5 (/)] APPLICATION FORM GRANT OF A LICENCE TO MANUFACTURE BY WAY OF FORMULATION/BASIC MANUFACTURE/SEMI-BASIC MANUFACTURE/REPACKING I/We ...........of .........hereby apply for the grant of a licence to manufacture by way of........................on premises situated at ................... 2. The drug(s) or class(es) of drugs intended to be manufactured :- (1) Class(es) of drugs. (2) Dosage form(s) of drugs. (3) Name of the drug(s). 3. I enclose :- (i) Particulars regarding the legal status of the applicant (i.e. in case of proprietorship the names) of proprietors and their address (es), in the case of firm the name and names and addresses of its partners and in the case of company the name and address of the company and its directors). (ii) Details of the premises including layout plan of the factory. (iii) Details of the section-wise equipment and machinery for manufacture and quality control. (iv) Names and qualifications of the Production Incharge and Quality Control Incharge for supervising manufacturing processes and Quality Control Department, and other technical staff working in these departments. 4. The premises and plan will be ready for inspectionon or are ready for inspection. Dated.................. Signed…………………… Place.................... Name, designation and address ........................ ----------------------- PROFORMA DETAILS OF THE FIRM Name of the Company ...................Type of ownership (Partnership, Proprietorship, Public limited, Private limited, etc.) Name(s) of Proprietor(s)/Director(s)/Partner(s). Date of Establishment. Initial investment (and details of equity shares). Present investment (and details of equity shares). Profit and loss statement as per audited accounts for the last five years : Year Investment Turnover Profit before tax Percentage 1% before tax for Central Research Fund percentage of Profit Calculated Paid investment Turnover Note: Copies of balance sheets to be enclosed with the application for renewal only"; and (6) in. Schedule B, in paragraph (2), in clause (k), for the semi colon and word"; and" a colon shall be substituted and thereafter the following proviso shall be inserted, namely: Provided that the conditions of location may be relaxed by the Board in suitable cases for grant or renewal or a licence subject to such conditions as it may deem fit, if the surroundings and the premises, in the opinion of the Board, are satisfactory for the intended manufacture. ---------------- FORM 1-A [See rule (5(I)] APPLICATION FORM FOR RENEWAL OF A LICENCE TO MANUFACTURE DURGS BY WAY OF FORMULATION/BASIC MANUFACTURE/SEMI-BA SIC MANUFACTURE/REPACKING I/We ............................ of ........................ hereby apply for the renewal of a licence to manufacture by way of on premises situated at .................................... 2. The drug(s) or class(es)of drugs intended to be continued to be manufactured:- (i) Class(es) of drugs. (ii) Dossage form(s) of drugs. (iii) Name of the drug(s) registered/approved. 3. There have been/have not been any change in respect of (i) Name of the proprietor/directors/partner(s) (ii) Details of the premises including layout plan of the factory. (iii) Details of the section-wise equipment and machinery for manufacture and quality control. (iv) Names and qualifications of the Production Incharge and Quality Control Incharge for supervision of manufacturing processes and Quality Control Departments, and other technical staff working in these departments 4. Statement of the Central Research Fund. Attested copies of the last two income tax assessment orders of the Income Tax Department attached. Following statement, as per audited accounts/based on Income Tax Return for the last five years:- Year Investment Turn-over CRF due C R F paid as per Col. 4 1 2 3 4 5 Date Signed…………………………. Place Name, designation and address of the signatory ....................... Note:-Strike off which is not applicable ---------------------- FORM 2 [See rule 7] GOVERNMENT OF PAKISTAN Licence to Manufacture is/are hereby licensed to manufacture by way of Basic Manufacture/Semi Basic manufacture/Formulation/Repacking at the following premises:- 2. This licence permits the manufacture of 3. This licence shall, in addition to the conditions specified in the rules made under the Drugs Ordinance/Act, 1976, be subject to the following conditions namely:- (i) The licence will be in force for a period of five years from the date of issue unless earlier suspended or cancelled. (ii) The licence authorises the sale by way of wholesale dealing and storage for sale by the licensee of the products manufactured under this licence, subject to the conditions applicable to licences for sale. (iii) Name of the approved expert staff. ....................................... ....................................... ....................................... ....................................... Date of issue ................. Secretary, Central Licensing Board. (Seal) Chairman, Central Licensing Board. FORM 2A (See rules 19 and 30) Warranty under Section 23(I)(i) of the Drugs Act, 1976 I...................being a person resident in Pakistan, carrying on business at (full address) .................. under the name of.....................(and being an importer/indenter/authorised agent of ..................), do hereby give this warranty that the drugs here-under described as sold/indented by me/specified and contained in the bill of sale, invoice, bill of lading or other document describing the goods referred to herein do not contravene in any way the provisions of section 23 of the Drugs Act, 19.76. Dated (Signed) 1. Name(s)· of the drug(s): (i) (ii) Batch number(s) 2. Description of bill of sale, invoice, bill of lading or other document (if any). Signed .............................. ------------------------ FORM 3 [See rule 21(I)] APPLICATION FOR LlCENCE TO MANUFACTURE DRUG(S) FOR EXPERIMENTAL PURPOSES. I/We ............... of ........... hereby apply for a licence to manufacture drug(s) specified below for experimental purposes at .......................... and I/We undertake to comply with the conditions applicable to the licence under rule 22 of the Drugs (Licensing, Registering and Advertising) Rules, 1976. 1. Name and quantity of drug(s) to be manufactured for the said purposes:. Signature............................ Name .............................. Address ........................... Countersigned by ....................... FORM 4 [See rule 21(3)] LICENCE TO MANUFACTURE DRUG(S) FOR EXPERIMENTAL PURPOSES Mr./Messrs .................... of .................. is/are hereby licensed to manufacture the drug(s) specified below for experimental purposes at ........................... :. or at such other place(s) at the. Central Licensing Board may from time to time permit. 2. The licence is subject to the conditions prescribed in rule 22 of the Drugs (Licensing, Registering and Advertising) Rules, 1976, and such other conditions as n3ay be subsequently prescribed or Specified by the Central Licensing Board in this behalf. 3. This licence shall unless previously suspended or cancelled be in force for a period of two years from the date specified below:- Name of drugs with quantity to be manufactured. Date:................. Place:................. Licensing Authority. FORM 5[See rule 26(I)] APPLICATION FORM FOR REGISTRATION OF A DRUG FOR LOCAL MANUFACTURE I/we.........................of ................hereby apply for registration of the drug namely ..................details of which are enclosed. Date ....................... Place ......................  ENCLOSURE OF THE APPLICATION FOR REGISTRATION OF A DRUG 1. Name and address of the manufacturer · 2, Name of drug · (a) Generic/international non-proprietory name: (b) Proprietory name, if any: 3 Name under which drug is proposed to be sold 4. Dosage from of the drug: 5. Composition of the drug, stating quantity of each active and non-active ingredient(s) per unit or as a percent age of total formulation : 6. Proposed dosage : (a) for adults. (b) children by age group. (c) infant (d) special groups. 7. Main Pharmacological group to which the drug belongs: 8. Pharmacological and clinical data : (a) recommended clinical use and the claims to be made for the drug. (b) contra-indications. (c) toxicity or the side-effects. (d) any directions for the use to be included in the labelling, warning and precautions in use : symptoms of over dosage should be given alongwith the treatment including antidotes, where required. 9. Proposed route of administration. 10. Description of the method of manufacture and quality control with details of the equipment. 11. Specifications, with details of analytical procedure for each ingredient and the finished drugs (not required in case of a drug for which pharmacopocial standards recognised under the Drugs Act, 1976, are claimed). 12. Bio-availability, Bio-equivalence and Pharmacokinetics Analysis (For Dosage Form Introducing first time in Pakistan). 13. Stability Summary : (a) A complete description of and date derived from studies on the stability of new drug, including information pertaining to the suitability of the analytical methods used (b) Shelf-life when stored under expected or directed storage conditions. (c) Recommended storage conditions and expiration date to be assigned to the specific formulation and package.. (d) Extreme Temperature Fluctuations Study for all liquid and semi-solid preparations. (Such observations should be utilized for appropriate labelled storage conditions or warning statements). (e) Type of container/package, with the nature of material, package testing (chemical, mechanical, environmental). 14. Labelling : Specimen or draft with colour scheme, alongwith the undertaking to refrain from counterfeiting shall also be submitted. 15. Pack size (s) and proposed maximum retail price with the following details:- (i) Cost per retail pack of each active and non-active. Ingredients : (ii) Cost of each packing material. (iii) Cost of direct labour, 16. Justification : (Only in case of a new entity). 17. Patent number, if any, with date and its date of expiry. 18. In case of a new drug (entity) not yet registered in Pakistan : (i) enclose certificate of registration and Free Sale from any of the following countries: Japan, USA and European Company Member countries. (ii) Any other relevant information that may be required by the Board for consideration of this application. FORM -5(A) [See rule 26 (1)] APPLICATION FORM FOR REGISTRATION OF AN IMPORTED DRUG I/We ........................of ..........................hereby apply for registration of the drug, namely....................details of which are enclosed. Date ....................... Place ...................... Signed........................... ENCLOSURES OF THE APPLICATION FOR REGISTRATION OF A DRUG 1. Name, address and status of the applicant: 2. Name and address of the manufacturer: 3. Name of the drug: (a) Generic international non-proprietory name: (b) Proprietory name, if any: 4. Name of drug, under which it is proposed to be sod: 5. Dosage form of the drug: 6. Composition of the drug stating quantity of each active and non-active ingredients per unit dose or percentage of total formulation: 7. Proposed dosage: (a) for adults. (b) children by age group. (c) infants. (d) special groups, 8. Main Pharmacological group to which the drug belongs: 9. Proposed route of administration: 10. Pharmacological and clinical data : (a) recommended clinical use and the claim to be made for the drug. (b) contra-indications. (c) toxicity or the side-effects. (d) any directions for. use to be included in the labelling warnings and precautions in use: symptoms of overdosage should be given alongwith the treatment including antidotes where required. 11. Specifications with details of analytical procedure (not required in case of a drug for which the pharmacopocial standards recognised under the Drugs Act, 1976 are claimed): 12. Bio-availability studies: 13. Stability studies : 14. Proposed shelf life with storage conditions, if any : 15 Type of container : 16. Labelling : (Specimen to be enclosed alongwith a .sample and undertaking to refrain from counterfeiting shall also be submitted) : 17. Proposed C and F and maximum retail price (in case of imported drug) : 18. Justification : 19. Certificate regarding sale and G.M.P. in the country of origin (in English and in Form 5 (c) : 20. Certificate of registration by F.D.A. of USA. Committee on Safety of Medicines of U.K. or corresponding agencies of France, West Germany, Japan, Sweden. and Denmark. 21. Patent number, if any, with date and its date of expiry : 22. Undertaking to manufacture drug locally within two years. If it is not possible, the reasons therefor. FORM-5B [See rule 26(3A)] APPLICATION FORM FOR RENEWAL OF REGISTRATION OF ALL KINDS OF DRUGS I/We .................... of ................. hereby apply for renewal of registration of the drug, namely .................details of which are as follows · 1. Name and address of the manufacturer: 2. Name and address of the agent or indentor in case of imported drug - 3. Whether the drug is registered for local manufacture or import · 4. Name of the registered drug, with its registration number and date or initial ,registration and last renewal ' 5. Changes, if any, in information furnished at the time of initial registration or last renewal 6. If withdrawn from the market anywhere · (i) Country. (ii) Reasons thereof. Place..................... Signature .................. Date....................... Name, and address of the signatory ............................ FORM-5C TO WHOM IT MAY CONCERN CERTIFICATE OF DRUGS REGISTERED UNDER THE DRUGS ACT, 1976 Name and dosage form of product ......................................... Name and amount of each active ingredient ............................................................................................. Manufacturer and or when applicable the person responsible for Placing the Product on the market ............................ Address(es)...................................................................... It is certified : * This product has been authorised to be place of the market for use in this country. *Number of Registration and date of issue if plicable. *This product has not been authorised to be placed on the market for use in this country for the following reason- .......................................................................................................................... .......................................................................................................................... .................................................................................. ........................................ It is also certified that (a) the manufacturing plant in which the product is produced is subject in inspections at suitable intervals, and (b) the manufacturer conforms to requirements for good practices in the manufacture and quality control, in respect of products to be sold or distributed within the country of origin or to be exported. (Signature of designated authority (Place and date) FORM 6 [See rules 28 and 29(4)] GOVERNMENT OF PAKISTAN CERTIFICATE OF REGISTRATION Certified that following drug(s) are hereby registered under the Drugs Ordinance/Act, 1976:- Name of Drug(s). Name of Manufacturer. Name of Indenter/Manufacturer's agent/Importer (in case of imported drugs only). 2. This registration shall be valid for a period of five years unless earlier suspended or cancelled. 3. This registration is subject to the conditions specified in the Drugs Ordinance/Act, 1976, and .the rules thereunder and to the conditions specified in the enclosure. Date of Registration Secretary Registration Board (Seal) Chairman. Registration Board FORM 7 [See rule 30(6)] STATEMENT SHOWING QUARTERLY PRODUCTION TO BE SUBMITTED IN DUPLICATE Name of drug. _________________________ Pharmacological group _________________________ Name of the Firm. _________________________ Address. _________________________ For the quarter ending. _________________________ Pack size. No. of Pack Total quantity in terms of individual units e.g., total No. of tablets, injections tubes litres etc. 1 2 3 VALUE (in Rs.) Details of Disposal On trade price On retail price Indicate whether supplied through normal distribution, channels or exported or supplied to any specific institution. Value of raw materials used (Active & inactive) (in Rs.) 4 5 6 7 Total.

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