Remarks. 6.5 Finished Pharmaceutical Products General (2) Dosage form(s) of drugs. (ii) Testing Procedures 18. 65. 6 wherever necessary. Condition for the grant or renewal of a licence to manufacture drugs by way of repacking: Before a licence to manufacture drugs by way of repacking is granted or renewed, the Central Licensing Board shall satisfy itself that the following conditions are complied with by the applicant, namely :-- 7.4.1 Avoiding mix-ups SECTION--3 10,000By way of semi-basic Rs. of tablets, injections tubes litres etc. Pharm.D. in Pharmacy. (4) Compressing machine. (3) The members of the Central licensing Board, other than its ex officio members, shall hold office for three years and shall be eligible for renomination. Safety instructions should be strategically displayed in local language. (b) the Director, Health Services of, each Provincial Government; Provided further that, if in the opinion of the Registration Board it is necessary so to do in the Public interest, it may provisionally register a [.] drug for period of two years. Zinc Oxide. 3.6.5 Investigations (B) For the renewal of Registration This Executive Order relates to criminal background checks by fingerprint and only affects licensing for audiologists, speech-language pathologists, licensed independent mental health practitioners, occupational therapists, and occupational therapy assistants. (b) Wells: Walls as far as possible should be protected by non-flammable or slow burning material. 1. (3) A suitable power driven mixer. PH of the solution wherever applicable. 17. May include compounding Non-Resident Type of licence Fee 1. Conditions for grant or renewal of a licence to manufacture drugs by way of basic or semi-basic manufacture: (1) Before a licence to manufacture by way of basic or semi-basic manufacture is granted or rehewed, the Central Licensing Board shall satisfy itself that the following conditions are complied with by the applicant, namely :-- (1) Storage equipment for ampoules and vials Issuance of a drug-sales license or pharmacy license is a procedure given by the Pharmacy council of Pakistan (PCP). 4.9 S.O.Ps for Sanitation 7.1.5 Avoiding mix-ups WHICH IS PROHIBITED Address 3.4.1 General Care for biological indicators Control reference numbers in respect of the lot of glass containers used for filling. Benzoic Acid. 14. SCHEDULE B I-A. Description of bill of sale, invoice, bill of lading or other document (if any). (a) the name under which the drug may be sold; 10.1.5 Product labelling 7.3.8 Equipment calibration (ii) Adequacy Date of issue .. (4) In the room provided for aseptic filling and sealing, necessary measures for maintaining sterility and to preventing contamination shall be adopted. (See rules 19 and 30) (2) When lay language is used the information shall be consistent with the approved scientific data or other legally determined scientific basis for approval. Once you determine where you wish to practice pharmacy, you will apply for a license through the respective State Board of Pharmacy. or the director or manager of the firm or company by which, the drug will be manufactured. 7.2.1 Precautions against dust (4) Antidandruff preparations. The drug(s) or class(es)of drugs intended to be continued to be manufactured:- Air supply system 16. (i) Country. 4.6 Duties of Production Incharges 10.3 Batch processing records 14. Phone - (717) 783-7156. 5. (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. (D) The following equipment is required for the manufacture of Powders :-- 2 Examinations. 53. FORM 7 4.9.1 Health examination (3) The licence for the manufacture of drugs for experimental purposes shall be in Form 4. 4. (3) Where inspection under sub-rule (2) is carried out by a Sub-Committee or panel of experts or Inspectors appointed under the said sub-rule, it shall forward to the Registration Board a detailed report of ;he result of the inspection. 4.9.3 Illness 1. 5. Toxins. (e) dosage form or regimen; Central Licensing Board may from time to time permit. Islamabad | Karachi | Lahore | Peshawar | Quetta; Phone: 0800-03727 (Mon to Fri 08:00AM to 04:00PM) Website: www.dra.gov.pk; 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. 3.7.1 System Duration of certificate of registration: A certificate of registration under this chapter, shall, unless earlier suspended or cancelled, be. (2) Ampoule washing and drying equipment. Use the following forms and instructions to complete the application process: License Examination Instructions. How to get a pharmacy license in Pakistan? 9. Cough Preparations. The Doctor of Pharmacy (Pharm.D.) (f) one pharmaceutical chemist or expert in quality control, to be nominated by the Federal Government; SECTION-1 (b) major indication(s) for use; (S.R.O. The benches shall preferably have stainless steel or laminated plastic tops capable of being washed. 4. Pharmacological group _________________________ (5) A fee of rupees fifty shall be paid for a duplicate copy of the certificate of registration if the original is defaced, damaged or lost, and such copy of the certificate shall bear the words "Duplicate Copy". (4) Tube filling equipment. (a) To ensure that sealed ampules are leak-proof, 7.4.2 Pre-packaging checks DRUG REGISTRATION FEE (aa) "marketing authorization" means a document, issued by the Drug Registration Board set up under the Drugs Act, 1976, as a certificate of drug registration; 16. (iii) Written Procedures (5) Dental preparations. [See rule 21(3)] In order to apply for a license or submit a service request, you must first have a DELPROS user account. Equilibrium with humidity and temperature (E) The following equipment is required for filling of Hard Gelatin Capsules:- 10. [See rule 7] GOVERNMENT OF PAKISTAN An area of minimum of 300 square feet is required for the basic installations. 2. While advertisements shall take account of peoples legitimate desire for information regarding their health they shall not take undue advantage of peoples concern about their own health. SECTION--4 6.2.8 Released materials to be used (8) The licensee shall allow any member of the Central Licensing Board or of a Provincial Quality Control Board or an Inspector to enter, with or without prior notice, any premises and to inspect the plant and the process of manufacture & the means employed in standardising and testing the drugs and to take samples for test and analysis. (ii) Cost of each packing material. 536(1)/93 dated 23rd June 1993. 4.8 S.O.Ps for Testing 3.7.2 Authorized procedures ENCLOSURES OF THE APPLICATION FOR REGISTRATION OF A DRUG degree from a college accredited by the Accreditation Council for Pharmacy Education (ACPE). 2.2 Layout 9, Opinion and signature of the approved Analyst Pyrogen Tests:- 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. Pharmacists measure and sell prescription drugs. There should be no drains at all in plants and in warehouse. 2. (7) Two thousand rupees for renewal of a license of a Pharmacy and one thousand rupees for renewal of a license of a Medical Store Medical Store License Investment In Pakistan: Undoubtedly Pharmacy or Medical Store is one of the leading businesses in Pakistan form which you can earn high. that drug; 43. All emergency and safety equipment must be frequently and regularly checked and maintained to ensure its conditions satisfactory. (A) The following equipment is required for the manufacture of drugs for external appliances or suspense: (i) Equipment Form 1 (225 ILCS 85/9) To add the STUDENT designation to your Pharmacy Technician license, you must submit: Proof of your status as a Student in an approved College of Pharmacy OR APPLICATION FORM FOR RENEWAL OF A LICENCE TO MANUFACTURE DURGS BY WAY OF FORMULATION/BASIC MANUFACTURE/SEMI-BA SIC MANUFACTURE/REPACKING 4. 4. Antitoxins. In case, the pharmacy business combines retail and wholesale, a minimum of 15 square meters is required. 5. This licence shall unless previously suspended or cancelled be in force for a period of two years from the date specified below:- All arrangements for production and analysis must be in accordance with the registration and agreed by both parties. (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. Frequency of use of filter Pulv Gentian. (i) Results of assay. Any individual, LLP, partnership firm, OPC or company can apply for a drug license. By way of formulation Rs. Inspection of containers Sodium Salicylate. (6) Antacid and carminatives: 3.3.3 Test requirement for starting and packaging materials (iii) Name of the drug(s) registered/approved. If you want to do your own job as a pharmacist in the state of Maharashtra, then you . (c) Doors; Doors must be fire resistant preferably with self-closing system, Box 2649. (v) Drains in the country of origin (in English and in Form 5 (c) : (b) Shelf-life when stored under expected or directed storage conditions. (4) Water still or Deioniser. 4. Rs. Employers shall be responsible for the basic and continuing training of their representatives. Boric Acid. 7. (as) "reprocessing" means the reworking of all or part of a batch of product of an unacceptable quality from a refined stage of production so that its quality may be rendered acceptable by one or more additional operations; Application for registration of drugs and fees thereof: (1) An application for registration of a drug shall be made in Form 5 or 5-A in duplicate to the Registration Board addressed to its Secretary, and separate application shall be made for each drug. MANUFACTURE BY WAY OF FORMULATION 190.00 Renewal Fee. For assistance with licensing, please . 23. (9) No act or proceeding of the Central Licensing Board shall be invalid merely on the ground of the existence of any vacancy in, or any defect in the constitution of the Board. Liquid Paraffin Heavy. 4.4 Specifications for Finished Products (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. Dosage from of the drug: Starting any business requires a great deal of effort, information, practical know-how and the same is the case with pharmacy business, y. Biz Idea Pakistan: Paper Plates Making Business! (2) Where inspection under sub-rule (1) is carried out by a sub-commmittee or panel of experts of Inspectors appointed under the said sub-rule it shall forward to the Central Licensing Board a detailed report of the result of the inspection. 6.1.1 Quarantine 5.1 General responsibility of licensee (d) The applicant shall establish an independent Quality Control Department and maintain separate staff, premises and adequate laboratory equipment for carrying out tests of strength, quality and purity of the substances being or to be used in the manufacture. I enclose :- Sterility test reference on bulk batch wherever applicable. (4) Every drug shall be produced in sufficient quantity so as to ensure its regular and adequate supply in the market. 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. APPLICATION FORM GRANT OF A LICENCE TO MANUFACTURE BY WAY OF FORMULATION/BASIC MANUFACTURE/SEMI-BASIC MANUFACTURE/REPACKING General (r) "Form" means a form set forth in Schedule A; Fumigation It is certified : Note: Records racer, cling various tests applied (including reading and calculation) should be maintained and necessary reference to these records should .be entered in serial No. (vi) Environmental Controls and Denmark. Warranty under Section 23(I)(i) of the Drugs Act, 1976 Suitability of process Date of granulation wherever applicable. . Sodium Potassium Tartrate. (5) Mixing and storage tanks of stainless steel or of other suitable material. 3. SCHEDULE B-II Procedure to Follow When Applying for a License to Sell Drugs 1) Complete the form-5 that is mandated in the Drug Rules. (c) Identification. 4.11 Labels 6.9.1 Testing prepared reference standard Address. Signature of the expert staff responsible for the manufacture, (am) "quality control" means the part of good manufacturing practices concerned with sampling, specifications, and testing as well as the organization, documentation, and release procedures which ensure that the necessary and relevant tests are actually carried out and that materials are not released for use, nor finished products released for sale or supply until their quality has been judged to be satisfactory and it is involved in all decisions concerning the quality of the product; (14-A) The contributions made towards the Central 'Research Fund under sub-rule (14) shall be kept in such bank as the Federal Government may specify and shall be utilised in accordance with the Drugs (Research) Rules, 1978. 7. 4.8.2 Training appropriate to duties Use of vacuum Date and methods of filtration. (b) For the renewal of licence Provided that the Central Licensing Board may allow a portion of such contribution to be spent by the firm itself for research and development of new drugs or for establishing research laboratories when it is fully satisfied that such expenditure will be utilised for the said purpose effectively and properly. Changes, if any, in information furnished at the time of initial registration or last renewal Powers of Registration Board: The members of the Registration Board shall exercise all the powers of Inspector without restriction as the area, and shall have the powers of a Provincial Inspector in relation to Section 30. 4.9 Personal hygiene SECTION--6 3.7.9 All concerned to be informed 13. 10. 7. Sterilization by radiation Magnesium Carbonate. 7. 8. A pharmacy graduate from overseas who wishes to apply to the Council for registration must fulfill the following: 1. Sanitation 6.2.1 Purchase C.). In order to become a licensed pharmacist, you must hold a Doctor of Pharmacy (Pharm.D.) Graduates Pharmacist Licensure by Endorsement for Non-U.S. 9. (A) For the grant of Registration Rs. 8. 9. Name of the sample (g) Results of assay. (2) Kettle, gas or electrically heated with suitable mixing arrangement. Serial Number. Date of commencement of manufacture and date of completion. 3. Quantity received. 8. Bismuth Carbonate. Free samples of non-prescription drugs to the general public for promotional purposes.- There shall be no free sampling of non-prescription drug to the general public for promotional purposes. Precursor substance requirements for the sale of a restricted product. 3, Batch Size, 2. (vi) no person known to be suffering from communicable disease or to be a carrier of such a disease and no person with. (3) Substantiated information on hazards associated with the drug shall be reported to the Registration Board as a priority. 7.2.2 Measures against contamination Although health education aimed at children is highly desirable, drug advertisements shall not be directed at children. Main Pharmacological group to which the drug belongs: (g) "batch numbering system" means a standard operating procedure describing the details of the batch numbering; Ferric Ammonium Citrate. 5. (14) Leak tasting equipment. (All weighings and measurements shall be checked and initialled by the competent person in the section). 3.4.4 Frequency of self inspection (4) Storage tanks or pots. Advertisement shall not generally be permitted for prescription drugs or to promote drugs for certain serious conditions that can be treated only by qualified health practitioners. 4.8.4 Understanding concepts 3.6.4 Recording defects and investigation 6.1 Material, general Ephedrine Sulphate. Proposed C and F and maximum retail price (in case of imported drug) : (k) One physician, to be nominated by the Federal Government; (i) a degree in Pharmacy from a university in Pakistan or any other institution recognised by the Federal Government for the purpose of the Ordinance and has at least twelve months of practical experience in the manufacture of drugs; or 4.4 Quarantine (10) The Licensee shall, on demand, furnish to the Central Licensing Board or the Provincial Quality Control Board or to such authority as the Central Licensing Board may direct, from every batch of a drug, or from such batch or batches of drugs as it may from time to time specify, a sample for examination and, if required, furnish full Protocols of the tests which have been applied. An area of minimum of 200 square feet is required for the basic installations. (b) the content of active ingredient(s) per dosage form or regimen; 4. Proposed route of administration. Ammonium Chloride. (i) one representative of the Central Board of Revenue, not below the status of an officer of B-20, to be nominated by the Federal Government; Fax - (717) 787-7769. 6.6.4 Additional testing of reprocessed materials 7.4.11 Destruction of un-used packaging materials Analytical report number. To get a medical store license, you must complete a 2-year Pharmacy Technician B Category diploma. Zinc Sulphate. (c) toxicity or the side-effects. 4, Date of receipt of sample (2) All claims concerning a drug for the purposes of promotion shall be reliable, accurate, truthful; informative, balanced, up to date, capable of substantiation and in good taste. Proposed dosage : (t) "good manufacturing practices for pharmaceutical products" means part of quality assurance which:-- (2) Analgesic Balms/Plasters. Perform location analysis 3. Post-marketing scientific studies, surveilance and disseminaion of information.- (1) The Registration Board shall be made aware of any post-marketing clinical trials for drugs that are conducted and the results thereafter as soon as possible. 2.3 Construction (i) If the application for renewal if made before the expiry of period of validity of licence. Details of Disposal 10. In the case of operations involving floating particles of fine powder or dust a suitable exhaust system shall be provided, Workers shall be provided with suitable marks during operation. GOOD MANUFACTURING PRACTICES (GMPs) FOR LICENCE TO Pharmacological and clinical data : (2). 5.1 Sanitation (a) rupees one thousand for the registration of new drug; [See rule 5 (/)] Test Report number. (13-A) The licensee or his authorised agent shall issue a warranty in Form 2-A For any drug sold by him for the purpose of re-sale or distribution. Pharmacy Licensing | Washington State Department of Health Thank you for your patience as we continue to update our new website. Rs. Sterilized surgical lignature and sterilized surgical suture. Name of the item. 2,500 29. (2) No person who is a member of the Appellate Board shall be nominated to the Central Licensing Board. Promotional material shall not be designed so as to disguise its real nature. Calcium Hydroxide. ------------------------ Pack size (s) and proposed maximum retail price with the following details:- (4) If the Central Licensing Board is not so satisfied, it shall reject the application and shall inform the applicant of the reasons for such rejection and of the conditions which must be satisfied before a licence may be issued. 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Individual pharmacy license requirements in pakistan LLP, partnership firm, OPC or company by which, the drug be..., gas or electrically heated with suitable Mixing arrangement Central Licensing Board may from time time! May from time to time permit 1 ) /93 dated pharmacy license requirements in pakistan June.!
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