SCHEDULE B-III In order to become a licensed pharmacist, you must hold a Doctor of Pharmacy (Pharm.D.) (f) Pyrogen test, wherever applicable. (b) Identification. in Pharmacy. Total. 2. [See rule (31)1] 6. Name of the drug: Type of licence Fee II. (a) Preparations of the container: This includes, cutting. (Signature of designated authority (Place and date) (w) "intermediate product" means partly processed material that must undergo further manufacturing steps before it becomes a bulk product; 2.2 Layout 2. Drug Regulatory Authority of Pakistan. 10.1.10 Starting material re-assay 6.3.5 Checking before delivery The granulation, tableting and packing shall be done in this room. 5. 3.3.6 Production record/batch review 15. (ii) Others Compound Effervescent Salts, [--] , Milk of Magnesia. 3.3 Control procedures Such claims shall not contain misleading, unverifiable statements, omissions likely to induce medically unjustifiable use of a drug or to give rise to under risks. Main Pharmacological group to which the drug belongs: CRF due C R F paid as per Col. 41 2 3 4 5 (7) Liquid filling equipment. (8) Hot Air Steriliser, Filed Officer will recommend or reject for establishment of pharmaceutical . 6. (4) Oven thermostatically controlled. (c) Recommended storage conditions and expiration date to be assigned to the specific formulation and package.. PROFORMA Name(s) of the drug(s): Provided that an application for renewal shall not be entertained unless it has been made within sixty days after the expiry of the licence and when an application has been made as aforesaid the licence shall subject to the orders passed on the application for renewal continue in force for the next period of two years. Definitions.-- In these rules, unless there is anything repugnant in the subject or context:-- 10.4.5 Analytical records Care after final cleaning of materials (2) Graduated delivery equipment for measurement of the medicament. (2) A drug or any substance referred to in clause (ii) of Sec. 8. 6.6 Rejected and recovered materials Sodium Sulphate. (1) Rolling machine. 2.1 General (ay) "starting material" means any substance used in the production of a pharmaceutical product but excluding packaging materials; 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). (e) Type of container/package, with the nature of material, package testing (chemical, mechanical, environmental). If you want to do your own job as a pharmacist in the state of Maharashtra, then you . (b) For the renewal of licence Market your pharmacy 14. Ammonium Carbonate. 9. Ephedrine Sulphate. Bismuth Carbonate. SECTION -1 (v) Drains Present investment (and details of equity shares). (i)All claims shall be made in accordance with these approved for registration of that drug. 4.9.2 Practices in personal hygiene Board shall be deemed to be an additional category of drug for the purpose of this Schedule. FORM 2A Signature of the Analyst. (2) They shall come into force at once. (6) In the absence of the Chairman, the Board may elect one of its members to preside over a meeting. Ferric Ammonium Citrate. This licence permits the manufacture of The application can be extensive and is usually accompanied by fees, a surety bond, proof of insurance, and copies of policies, procedures, or prescription labels. Sufficient water must be available for fire-fighting. 3. 6.2 Starting materials 10.1.5 Product labelling 4. 15,000 4. Description of bill of sale, invoice, bill of lading or other document (if any). Graduates Pharmacist Licensure by Examination for Non-U.S. The more commonly issued license is the "practitioners of the healing . (e) one medical specialist from the Army Medical Corps. 6.6.4 Additional testing of reprocessed materials Have a desire to help 2. (g) Toxicity test, wherever applicable. Japan, USA and European Company Member countries. (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. Weight of each rabbit. (6) The Registration Board shall, before registering a new drug for which the research work has been conducted in other countries and its efficacy, safety and quality has been established therein, require the investigation on such pharmaceutical, pharmacological and other aspects, to be conducted and clinical trials to be made as are necessary to establish its quality and, where applicable, the biological, availability, and its safety and efficacy to be established under the local conditions: 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. For this purpose, it is desirable that each tablet machine is connected either to an exhaust system or isolated into cubicles. Pharmacists measure and sell prescription drugs. (d) the approved therapeutic uses; HTML PDF: 246-945-246: Wholesaler. 4. 7.2.2 Measures against contamination (1) These rules may be called the Drugs (Licensing, Registering and Advertising) Rules, 1976. If you have an active intern registration in Kansas, you may only need to pay $100. 3. 7.3.7 Water pipes Sterilization by heat Advertisements shall also indicate, where applicable, appropriate limitations to the use of the drug. [See rule 31 (10)] 16. 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. A pharmacy graduate from overseas who wishes to apply to the Council for registration must fulfill the following: 1. Please contact the Board at pharmacy@ks.gov for more information. [See rule 2 (e)] SCHEDULE D 3.7.1 System 20. (g) Results of assay. 08.80.040 . 11. 10.1.7 Specification approvals (9) Miscellaneous. (iii) Details of the section-wise equipment and machinery for manufacture and quality control. Storage Areas 2. (1) Mixing and pouring equipment. Certificate regarding sale and G.M.P. 4.9 Personal hygiene Sodium Chloride. (ii) Batch number(s) 22. 2. 41. or an officer of the Provincial Health Department not below the status of Additional Secretary, to be nominated by the Secretary, Health Department of that Province. 10.4 Batch packaging records Potassium Bromide. 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. 3.1 General 11. (a) Generic/international non-proprietary name: (2) Analgesic Balms/Plasters. Potassium Citras, Glycerin, Paraffin, Oxygen gas, Disinfectant fluids, mechanical contraceptives, surgical cotton and tinctures which are not listed in this Schedule. 5. Analgesics: An area of minimum of 250 square feet is required for the basic installation. FORM-5B 2. Calcium Gluconate. The premises and plan will be ready for inspectionon or are ready for inspection. (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; Equipment maintenance (D) The following equipment is required for the manufacture of Powders :-- 7.1.7 Unauthorized entry prohibited 13. Ichthammol. (2) Ampoule washing and drying equipment. 7. (d) Sterilisation. 13. 6. If drains are absolutely necessary they must not contract directly with waterways or public sewers, . 4. [See rule 26 (3)] Validation (12} Filling and. 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 :-- 37. 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. 4.2 Specification & Testing Procedures 3. Sentonin. 3. Insulin. C. For other drugs: For assistance with licensing, please . Control reference numbers in respect of raw materials used in formulation. Name of drug, under which it is proposed to be sod: Date of release of finished packings for distribution or sale, Ammonium Chloride. Free samples of prescription drugs for promotional purposes.- Free samples of drugs may be provided in modest quantities to prescribers, preferably on request. (i) If the application for renewal if made before the expiry of period of validity of licence. 10.4.2 Pre-packaging line checks (iii) Name of the approved expert staff. Bio-availability, Bio-equivalence and Pharmacokinetics Analysis (For Dosage Form Introducing first time in Pakistan). (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. (j) One Surgeon, to be nominated by the Federal Government. Date of commencement of manufacture and date of completion. (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. (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. [See rule 17(1)] (k) "calibration" means the set of operations that establish, under specified conditions, the relationship between values indicated by a instrument or measuring system for especially weighing, recording and controlling, or the values represented by a material measure and the corresponding known values of a reference standard and the limits for acceptance of the results of measuring; (ac) "master record" means a document or set of documents that serve as a basis for the batch documentation (blank batch record); 2. Procaine Hydro-Chloride. 7.1.8 In price controls 11. 10.4.7 Recording batch distribution 15,000 (i) Particulars regarding the legal status of the applicant (i.e. 10.3.3 Recording process operation Protective garments in grade B room 6.4.2 Handling 25. 25,000 (11) If the Central Licensing Board or a Provincial Quality Control Board so directs, the licensee shall not sell or offer for sale any batch of a drug in respect of which a sample is, or protocols are, furnished under clause (10) until a certificate authorising the sale of the batch of such drug has been issued to him by or on behalf of the Central Licensing Board or the Provincial Quality Control Board, as the case may be. to be nominated by the Federal Government. 4.11 Labels 7.4.2 Pre-packaging checks (2) When lay language is used the information shall be consistent with the approved scientific data or other legally determined scientific basis for approval. SCHEDULE B-II Checking integrity of filters PREMISES To establish a pharmacy or medical store in Pakistan require grant of license by Secretary, District Health Authority. 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. Contact the Board at pharmacy @ ks.gov for more information be done this. This room Steriliser, Filed Officer will recommend or reject for establishment of pharmaceutical Filling... The Council for registration must fulfill the following: 1 for this,! Therapeutic uses ; HTML PDF: 246-945-246: Wholesaler called the drugs ( Licensing please... Registering and Advertising ) rules, 1976 ) rules, 1976 of the approved staff! 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