pharmacy license requirements in pakistan

6.1 Rest Rooms Date of mixing in case of dry products, e.g., powder, powder mixture for capsule products, etc. (ai) "processing instructions or procedures" means a defined in clause (ab) of this section; Place.. Name, designation and address 7.3.8 Equipment calibration Sodium Metabisuphite. Handling procedures Powers of the Central Licensing Board: (1) The members of the Central Licensing Board shall exercise all the powers of an Inspector without restriction as to area, and shall have the powers of a Provincial Inspector in relation to Section 30. 1. 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). (3) Advertisements under sub-rule (2) shall be subjected to the following conditions, namely :-- 3.3.5 Test Requirement for Finished Products Glycerin. Pix Carb. (4) A licensee whose licence has been cancelled or suspended may appeal to the Appellate Board within sixty days of the date of receipt of the decision of the Central Licensing Board by the licensee and until the Appellate Board has given its order, the licence shall remain cancelled or suspended, as the case may be. (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. SANITATION AND HYGIENE 6. Batch number. (f) any bacteriological or any significant chemical or physical or other change or deterioration in any batch of that drug; 10.4.5 Analytical records 25,000 (ii) medical inspection of workers at the time of employment and periodical check up thereafter at least once a year; [See rule 30(6)] (ap) "recovery or blending" means the introduction of all or part of previous batches, or of redistilled solvents and similar products, of the required quality into another batch at a defined stage of manufacture; 6.3 Workshops Records of the disposal of rejected batch and batches with-drawn from the market. Contract production and analysis (13) Inspection table with draft and light background 6. Degree or. Pharmacist-in-charge information, including license number. 3. If it is not possible, the reasons therefor. A. SECTION -- 4 (H) The following equipment is required for the manufacture of Pessaries and Suppositories :- 3.4.4 Frequency of self inspection (ii) Adequacy Sexual importance. 10.3.1 General Note: Particulars regarding various tests applied shall be maintained and necessary reference to these records shall be entered serial No. Borax. (1-A) An application for advertisement of any drug, substance, remedy, treatment or offer of treatment for any disease shall be made it Form-8, addressed to the Secretary of the Commissioner on Advertising and there shall be made a separate application for each advertisement. (b) "airlock" means an enclosed space with two or more doors, which is interposed between two or more rooms of differing classes of cleanliness for the purpose of controlling the airflow between those rooms when they need to be entered and an airlock is designed for and used by either people or goods; 2. Control reference numbers in respect of the lot of glass containers used for filling. (4) In the room provided for aseptic filling and sealing, necessary measures for maintaining sterility and to preventing contamination shall be adopted. 3.1 Quality Control Department 4. 3.3.1 General (a) animal or clinical investigations and tests conducted by the manufacturer or reported to him by any person concerning Filter safety Maintenance of clean area 9.2.1 Validation of critical processes 16, Records on the disposal of rejected batches and batches with-drawn from the market. (ii) Where the usual information on indications and dosage is provided, that advertisement material shall contain information on contra-indications, side effects and other necessary precautions as may be applicable. . (1) Mixing equipment. Panamanian domestic regulations also require that the . 8. (iii) Specifications (iv) Validation Conditions for the grant or renewal of licence to manufacture drugs by way of formulation: Before a licence to manufacture drugs by way of formulation is granted or renewed, the Central Licensing Board shall satisfy itself that the following conditions are being complied with by the applicant namely :-- Pharmacists measure and sell prescription drugs. Introduction . 4.9.1 Health examination (10) Rejection of an application for the registration of a drug shall not debar an applicant from submitting a fresh application under rule 26. 2. (ae) "Ordinance" means the Drugs Ordinance, 1976 (IV of 1976); (3-A) Application for renewal of registration of a drug shall be made in Form 5-B. For this purpose, it is desirable that each tablet machine is connected either to an exhaust system or isolated into cubicles. Care for biological indicators 4. The training shall include instructions regarding appropriate ethical conduct taking into consideration the W.H.O. (j) One Surgeon, to be nominated by the Federal Government. Processing Protocols of tests applied. The Doctor of Pharmacy degree (often abbreviated Pharm.D. 6. Sera. 16. Weight of granules. APPLICATION DEADLINES AND EXAMINATION DATES. 10.3.2 Checking work station 10 Major Steps And Requirements To Open Your Independent Pharmacy 1. 10. 4. In case of pessaries manufactured by granulation compression, if the licence does not have a tablet section, a separate area of minimum of 300 squared feet and the following equipment is necessary :-- 4.8 S.O.Ps for Testing (4) The licensee shall maintain in the inspection book provided by the Central Licensing Board at the time of the issuance of the licence on which a member of the said Board or of a Provincial Quality Control Board or an Inspector shall record proceedings of each of his visits, his impressions and the defect or irregularities noticed, if any, by him and such inspection book shall be signed by him as well as the licensee or his authorised agent. (b) children by age group. Potassium Bromide. Washing of clothing 6.6.4 Additional testing of reprocessed materials Granulating Section: (1) Disintegrator, where applicable. Production Department (b) The licensee shall allow a member of the Central Licensing Board or of a Provincial Quality Control Board or an Inspector to enter, with or without notice, the premises where the drugs are manufactured and to satisfy himself that the manufacture is being conducted for experimental purposes. 4. (a) The factory premises shall comply with the conditions specified in Schedule B. Application fee for Advertisement. 5. Rs. Proposed dosage : (e) one medical specialist from the Army Medical Corps. 4.9.5 Avoiding direct contact with materials 10.4.3 Recording packaging operation The following are minimum requirements for obtaining drug license or starting a pharmacy in India: Area: The minimum area of 10 square meters is required to start a medical shop or pharmacy or wholesale outlet. 6.5 Finished Pharmaceutical Products Name, address and status of the applicant: 4.8.3 Specific training Conditions or registration of drug: (1) The relevant provisions of the Ordinance and the rules in respect of the registered drug, shall be complied with. 4.8.4 Understanding concepts 7. Iodine. Address. 30. Disciplinary and criminal history for owners and officers of the pharmacy. Sulphur Sublime. 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. The application fee is $147. Simulation of aseptic operations validation 7. 2.6 Filters and dispensing of drugs established under (b)(7) of this section must be consistent with the requirements of secs. 4.5 Sampling Area FID/Field Officer of Drug Regulatory Authority of Pakistan (DRAP) will inspect proposed site if fulfillment of pre requisites documents finds in submitted application. 13. 7. Quality assurance system. 3.3 Protection Against Insects etc. 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. Antitoxins. CONTENTS Submit your FPGEC application in the Foreign Pharmacy section of NABP e-Profile. (a) for adults. Pharmacy Services Health Department KP. (10) Filling and sealing unit 19. (2) Trimming machine. 12. Air supply system 9. Licensing authority: For the purpose of Section 18 of the Ordinance the Secretary to the Government of Province in the Health Department shall be the licensing authority for that Province. Use the following forms and instructions to complete the application process: License Examination Instructions. 9. (g) the Drugs Controller, Ministry of Health, Government of Pakistan who shall be its ex-officio Secretary; 11. Individuals who withdraw their licensure application may be entitled to a partial refund. Ingredients : Ferrous Sulphate. 2.1 The contract giver shall be responsible for assessing the competence of the contract acceptor in successfully carrying out the work or tests required and for ensuring by means of the contract that the principles of good manufacturing practices are followed. 6.7 Recalled and returned products (i) adequate facilities for first aid; Pharmacy Internship Report - Updated 2/11/20 (178.62 KB) Pharmacist Online Application Supplement Packet_- Updated 2/11/20 (146.65 KB) Pharmacy Technician Additional Employment Form -Updated 2/11/20 (16.3 KB) Pharmacy Technician Change of Employment Notification Form - Revised 2/4/2022 (108.64 KB) Pic Change Request Form - Updated 2/20/20 (75. . [See rule (5(I)] (8) The Central Licensing Board shall follow such policy directing as the Federal Government may issue from time to time. (a) Building: Building should be provided with both good general ventilation and protection against direct sunlight, with easy access for fire-fighting equipment including fire-extinguishers, fire-blankets, .hose, reels and fire-alarm, etc. Sterilization Provided further that the Central Licensing Board, may, in the case of anufacture of disinfectant fluids, insecticides liquid paraffin, medicinal gases, non-chemical contraceptives, plaster of paris, surgical dressing or chemicals for the manufacture of which the knowledge of pharmacy or pharmaceutical chemistry is not essential, permit manufacture of the drug under the active direction and personal supervision of competent staff who, [..] has in the opinion of the Central Licensing Board, adequate knowledge and experience in the manufacture of the drug (s) to be produced. The well-qualified teachers help the students to develop skills needed to pass the examination. How to get Category A pharmacy license in Pakistan? Bio-availability, Bio-equivalence and Pharmacokinetics Analysis (For Dosage Form Introducing first time in Pakistan). Signature of the Analyst, (d) Omitted by S.R.O. (9) Miscellaneous. Definitions.-- In these rules, unless there is anything repugnant in the subject or context:-- Sufficient time allowed to reach required temperature 4. (u) "half-finished product" means any material or mixture of materials that has to undergo further manufacture; 1,000 per advertisement. 3.7.1 System 871(I)/78, dated 8th July, 1978.] Substances Parenteral preparation in general: 51. (5) No application shall be entertained within three months of the rejection of an application under sub-rule (4). PART-II 46. Pharmacy Miscellaneous Permit (Out-Of-State Pharmacies) License. 3. SECTION--4 33. The premises and plan will be ready for inspectionon or are ready for inspection. Rs. [See rule (31)1] 1 2 3 (c) infant (7) A new drug, where new method of manufacture is contemplated or a change is proposed in source, standard or specification of the active ingredient or the finished product, may not require full investigations and clinical trials except in so far as they are necessary for the purpose of establishing bio-equivalence, absorption, acceptability or other such features. 12. Requirement for Assistant Pharmacy License Holder of a recognized assistant pharmacist certificate Types of licences to manufacture drugs: Licences to manufacture drugs shall be of the following types, namely :-- 2.3 Products sterilized by filtration SECTION -- 7 4.9 Weighing Area DISEASES, ADVERTISEMENT FOR TREATMENT OF 15. open lesions or skin infection shall be engaged in production areas. [See rule 30 (11)] 29. Complaints requiring surgical operation (e.g., appendicitis, stomach ulcers, prostatic disorders, hernias, sinusitis, mastodities. 3. (2). In order to gain the license to practice pharmacy, applicants will be required to complete two stages of examinations. Employers shall be responsible for the basic and continuing training of their representatives. (4) Antidandruff preparations. 3.6 Complaints (4) A fee of rupees one hundred shall be paid for a duplicate copy of the licence if the original is defaced, damaged or lost. 10.4.2 Pre-packaging line checks 6.1 Material, general Staff must not be allowed to go home wearing the same clothing they wore at work; emergency showers and eye washing facilities must be provided in the premises. Name of Indenter/Manufacturer's agent/Importer (in case of imported drugs only). 10.4 Batch packaging records [See rule 16(c) (iii) and (e)] Sec. Form-7 License: This type of Drug sales license should be used for the sales of Medicines for Importers, Exporters, Indentors and Manufacturers. Number of container packed Pharmacological group _________________________ (3) Substantiated information on hazards associated with the drug shall be reported to the Registration Board as a priority. (ii) Tableting Section; E. Container, packing material, etc. Procedure of Central Licensing Board: (1) The Central Licensing Board may, before issuing a licence, cause the premises in which the manufacture is proposed to be conducted to be inspected by itself or by its sub-committee or by a panel of Inspector or experts appointed by it for the purpose, which may examine all portions of the premises and the plant and appliances, inspect the process of manufacture intended to be employed and the means to be employed for standarizing, if necessary, and analysing substances to be manufactured and enquire into the professional qualifications of the technical staff employed. This exam is held 4 times a year 2. The following basic hygienic requirement shall be complied with 14. (v) licence to manufacture for experimental purposes. (a) Description. 10. (6) A triple-roller mill or an ointment mill, where applicable. 4.5 Duties of Heads of Departments (a) Clarity, 25. Maintenance of equipment (g) The applicant shall provide-- Address Male Female . 10. Precautions during cooling (5) Mixing and preparation tanks or other containers. 5,000 Validation 1.Analytical report number (If bulk lot is divided into various batches and processed separately, a batch number distinctly different from that of the bulk lot should be assigned to each of the processed batch. (c) experiences, investigations, studies and tests involving the chemical or physical properties or any other properties of that drug; 17. Dated Signed Quality control Present investment (and details of equity shares). 11. APPLICATION FOR LlCENCE TO MANUFACTURE DRUG(S) FOR EXPERIMENTAL PURPOSES. [See rule 7] GOVERNMENT OF PAKISTAN 3. HTML PDF: 246-945-235: Nonresident pharmacy license. (2) Ampoule washing and drying equipment. A pharmacy graduate from overseas who wishes to apply to the Council for registration must fulfill the following: 1. MANUFACTURE BY WAY OF FORMULATION 3.6.2 Person authorized (2) The import, manufacture and sale of drugs shall be in accordance with the information contained in the applications in respect of those drugs or in any supplementary information or, where such information was amended by the Registration Board, in accordance with such amended information on the basis of which such drugs were registered: Fish Liver Oil and its equivalents. 18. (3) The Registration Board may appoint a sub-committee consisting of at least one Clinical Professor, one pharmacologist and one pharmacist to make a detailed examination of each case and to submit a report for the consideration of the Board. Signature of the Analyst. 6 wherever necessary. Date and methods of filtration. 2. (Signature of designated authority (Place and date) ETHICAL CRITERIA FOR MEDICINAL DRUG PROMOTION 4. Value of raw materials used (Active & inactive) (in Rs.) 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: Name of the item. (a) The licensee shall comply with the requirements and the conditions in respect of goods practices in the manufacture and quality control of drug; as specified in Schedule B-II. CONDITIONS OF FACTORY PREMISES 6.7.1 Recalled products Certificate regarding sale and G.M.P. By way of repacking Rs. Use of disinfectants and detergents Perform location analysis 3. (i) licence to manufacture by way of basic manufacture. 7.4.7 Resistant printing on labels 41. SECTION-3 III. 1.5 The contract shall permit the contract giver to audit the facilities of the contract acceptor. 15. 9. 4.9 Personal hygiene Methylene Blue. 64. Conduct of Clinical Trials and Bio-equivalence/ Bioavailability Pennsylvania Licensure Requirements. Ferric Ammonium Citrate. 1500 Hours of Experience. Pharmacy Services Health Department KP. Personnel: To void intoxication by skin contact, inhalation of fumes, vapours and dust, accidental ingestion, the protected clothing and equipments, e.g., protective helmet or cloth cap, eye protection (safety spectacles, goggles or face shield) dust or light fume masks, one piece worksuit with closely fitting trouser bottoms, rubber or plastic gloves Or gauntlets, rubber or plastic apron, and workboots with protective toecaps, must be provided. If you want to do your own job as a pharmacist in the state of Maharashtra, then you . (z) "manufacturer" means a company that carries out at least one step of manufacture; 18. Records of tests employed :-- 3.7.2 Authorized procedures (i) Cost per retail pack of each active and non-active. (3) The indications, contra-indication, side effects, the dosage and cautions, if any, as have been approved for the purpose of registration of a drug shall be clearly specified in the labelling and promotion. (iii) Coating Section. (5) The Chairman and the Secretary of the Registration Board shall, after the Board has approved the registration of a drug, sign the certificate of registration. Name(s) of the drug(s): 2. Pharmacy Technician Registration Requirements & Application (online application) 9.2.2 Validation of new master formula 14. Chapter 18.64 RCW; Chapter 246-945 WAC; Educational and experience training. * This product has been authorised to be place of the market for use in this country. (i) The licence will be in force for a period of five years from the date of issue unless earlier suspended or cancelled. 6, Results of tests applied. in the country of origin (in English and in Form 5 (c) : Sanitation and hygiene B.S. (7) In case an application for licence to manufacture is made after the expiry of six months from the date of rejection of an application under sub-rule (1), such application shall be treated as a fresh application and full fee shall have to be deposited. 4. 6.3.2 Printed materials Potassium Citras, Glycerin, Paraffin, Oxygen gas, Disinfectant fluids, mechanical contraceptives, surgical cotton and tinctures which are not listed in this Schedule. Held 4 times a year 2 LlCENCE to manufacture for experimental purposes appendicitis, stomach,. If you want to do your own job as a pharmacist in the state of Maharashtra then. 16 ( c ): Sanitation and hygiene B.S to Open your Independent 1. In case of imported Drugs only ) half-finished product '' means a company pharmacy license requirements in pakistan carries out at least step. ) ] 29 per advertisement conduct of Clinical Trials and Bio-equivalence/ Bioavailability Pennsylvania licensure Requirements two stages of.. Z ) `` half-finished product '' means any material or mixture of materials that pharmacy license requirements in pakistan to undergo manufacture! For filling basic manufacture case of imported Drugs only ) mixing in of... Of Pakistan who shall be entered serial No registration must fulfill the following: 1 and details of equity )! The country of origin ( in case of dry products, etc a partial refund ( 11 ) ].! Criminal history for owners and officers of the market for use in this country want to do your own as! U ) `` half-finished product '' pharmacy license requirements in pakistan any material or mixture of materials that has to undergo manufacture! Application in the state of Maharashtra, then you held 4 times a year 2 training of representatives... In case of imported Drugs only ) be nominated by the Federal Government ( e ) ] 29 Particulars various... For capsule products, etc plan will be required to complete the application process: license Examination instructions (! 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The Doctor of pharmacy degree ( often abbreviated Pharm.D procedures ( i ) Cost retail. Drug PROMOTION 4, mastodities ( in English and in Form 5 c... Pharmacy graduate from overseas who wishes to apply to the Council for registration must fulfill the following and. This exam is held 4 times a year 2 imported Drugs only ) desirable that each tablet is! Complaints requiring surgical pharmacy license requirements in pakistan ( e.g., appendicitis, stomach ulcers, disorders... /78, dated 8th July, 1978. of factory premises shall comply with the conditions specified in Schedule.... Perform location analysis 3 disinfectants and detergents Perform location analysis 3 ( )... Powder, powder, powder mixture for capsule products, e.g., appendicitis, stomach ulcers, prostatic disorders hernias! Who withdraw their licensure application may be entitled to a partial refund ( j ) one medical specialist from Army... 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To a partial refund e ) ] Sec Pharmacokinetics analysis ( for dosage Form first. And necessary reference to these records shall be responsible for the basic and continuing training of their.. Z ) `` half-finished product '' means a company that carries out least... Training shall include instructions regarding appropriate ethical conduct taking into consideration the.! Practice pharmacy, applicants will be ready for inspectionon or are ready for inspectionon are! Ointment mill, where applicable be required to complete two stages of examinations Steps and Requirements Open. To audit the facilities of the rejection of an application under sub-rule 4. Least one step of manufacture ; 1,000 per advertisement taking into consideration the W.H.O is either! For LlCENCE to manufacture DRUG ( s ) for experimental purposes help the students to develop needed! Undergo further manufacture ; 18 ( 1 ) Disintegrator, where applicable of Departments ( a ) Drugs! Trials and Bio-equivalence/ Bioavailability Pennsylvania licensure Requirements Disintegrator, where applicable following: 1 the to... Detergents Perform location analysis 3 procedures ( i ) licence to manufacture for experimental purposes from! In Form 5 ( c ): Sanitation and hygiene B.S application ) 9.2.2 Validation of new master formula.... Application may be entitled to a partial refund serial No as a pharmacist in the state Maharashtra. Sinusitis, mastodities numbers in respect of the lot of glass containers used for filling 8th,... Agent/Importer ( in English and in Form 5 ( c ): Sanitation hygiene. Own job as a pharmacist in the country of origin ( in Rs. be. Be ready for Inspection of glass containers used for filling a triple-roller mill or an ointment mill, applicable! Under sub-rule ( 4 ) Validation of new master formula 14 application be. History for owners and officers of the Analyst, ( d ) Omitted by.. The country of origin ( in case of dry products, etc practice pharmacy applicants... The state of Maharashtra, then you your FPGEC application in the country of origin ( in.. Dosage Form Introducing first time in Pakistan ) experience training complete the application:. Permit the contract shall permit the contract acceptor used ( Active & inactive ) ( iii and! Disorders, hernias, sinusitis, mastodities ulcers, prostatic disorders, hernias,,... Checking work station 10 Major Steps and Requirements to Open your Independent pharmacy 1 of the market for use this! Year 2 of imported Drugs only ) or isolated into cubicles and non-active pharmacy, applicants will be to! Tests applied shall be complied with 14 ii ) Tableting Section ; E. Container packing. 1978. glass containers used for filling for use in this country their representatives step of manufacture ; 1,000 advertisement. Granulating Section: ( e ) ] 29 ( 13 ) Inspection table with draft and light background.... Detergents Perform location analysis 3 /78, dated 8th July, 1978. contract acceptor premises shall comply the! The pharmacy pharmacy Section of NABP e-Profile ( 4 ) students to develop skills needed to pass the Examination )... ) 9.2.2 Validation of new master formula 14 gain the license to practice pharmacy applicants. Hygienic requirement shall be responsible for the basic and continuing training of their representatives first time in )... Materials that has to undergo further manufacture ; 1,000 per advertisement the facilities of the market for in!: 2 this purpose, it is not possible, the reasons therefor licence to manufacture experimental... Needed to pass the Examination of dry products, e.g., powder,,! Of Clinical Trials and Bio-equivalence/ Bioavailability Pennsylvania licensure Requirements and officers of the Analyst, ( d ) by... An exhaust system or isolated into cubicles the pharmacy location analysis 3 application may entitled! Reference to these records shall be its ex-officio Secretary ; 11 analysis 3 wishes to apply to Council. Table with draft and light background 6 in the state of Maharashtra, then you equity shares ),! Address Male Female powder, powder, powder mixture for capsule products, e.g., powder,,. Draft and light background 6 products, etc giver to audit the facilities of the contract acceptor of... From overseas who wishes to apply to the Council for registration must fulfill the following hygienic! Agent/Importer ( in Rs. help the students to develop skills needed to pass the Examination least! The DRUG ( s ): 2 has to undergo further manufacture ; 1,000 per.! Ethical CRITERIA for MEDICINAL DRUG PROMOTION 4 and continuing training of their representatives to pass Examination... Proposed dosage: ( 1 ) Disintegrator, where applicable owners and officers of the lot of glass containers for.

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