Sexual importance. Sterilization General (8) Hot Air Steriliser, Each of our licensure programs fulfils different pharmacists' needs. Note: Particular regarding various tests applied (including reading and calculations) shall be maintained and necessary reference these records shall be entered in serial No. (3) Weighing and measuring equipment. in the country of origin (in English and in Form 5 (c) : [Omitted vide S.R.O. 3.6.8 Review for Reviewing Problem Monitoring of clean areas 2. REQUIREMENTS OF PLANT AND EQUIPMENT (5) If any defects or irregularities are recorded in the inspection book under sub-rule (4) the manufacturer shall take steps to remove such defects or irregularities. (i) "biological agents" means micro-organisms, including genetically engineered micro-organisms, cell cultures and endoparasites, whether pathogenic or not; (3) Filter press or other suitable filtering equipment such as metafilter or sparklet filter or Also-pad filter. LICENCE TO MANUFACTURE DRUG(S) For Foreign-trained Pharmacy Graduates / Pharmacists. We recommend that you send all supporting documentation to NABP at the time of submitting your application. Process to apply for a Drug sales License: 1) Fill a prescribed form-5 in Drug Rules. 3.2 The contract acceptor shall refrain from any activity that may adversely affect the quality of the product manufactured and or analyzed for the contract giver. (b) Shelf-life when stored under expected or directed storage conditions. To establish a pharmacy or medical store in Pakistan require grant of license by Secretary, District Health Authority. Water supply 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. (c) experiences, investigations, studies and tests involving the chemical or physical properties or any other properties of that drug; Don't have an Account? 5. (4) Filling equipment. 2.2 The contract giver shall provide the contract acceptor with all the information necessary to carry out the contracted operations correctly in accordance with the registration and any other legal requirements and the contract giver shall ensure that the contract acceptor is fully aware of any problem associated with the product, work, or tests that might pose a hazard to premises, equipment , personnel, other materials or other products. (A) For the grant of Registration Rs. Potassium Bromide. CONDITIONS OF FACTORY PREMISES (d) Volume in container, (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. and dispensing of drugs established under (b)(7) of this section must be consistent with the requirements of secs. 5.3 General Requirements for Production Areas (5) Filling equipment, III. Remarks. [See rule 26 (1)] 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. Degree or. (c) two pharmacologists, to be nominated by the Federal Government. Sodium Benzoate. 6.4 Animal House (al) "quality assurance" means the totality of the arrangements made with the object of ensuring that pharmaceutical products are of the quality required for their intended use and so incorporates good manufacturing practices, Quality Control and other factors including product design and development and good laboratory practices; 3. 4.3 Specifications for Starting and Packaging Materials 21. 6.2.6 Labelling (2) Where a person possesses or applies for a licence to manufacture by way of formulation and he also intends to conduct repacking of drugs, he may conduct such repacking under the same licence subject to the approval of, and under such conditions as, the Central Licensing Board may specify. (2) Granulator. Venereal diseases. (1) Mixing equipment. 6. After the DHA have pre-evaluated your documents, they will send you an email that contains the link to have your Primary Source Verification done. Precautions against contamination 16. (a) on request, report in duplicate of all records respecting the information contemplated by paragraphs (d), (e), and (f) of (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; Cetrimide Powder. 1. Record maintenance Pharmacological and clinical data : (iii) Specifications By way of formulation Rs. 18. SCHEDULE B I-A. 18. 20. Name of Indenter/Manufacturer's agent/Importer (in case of imported drugs only). 15. FORM 6 (3) Cutting equipment. Previously, an applicant or proprietor had to go to the Secretary's office of the District Quality . (f) Any other tests. Particulars regarding the precautions taken during manufacture to ensure that aseptic conditions are maintained. The Tableting Section shall be free from dust and floating particles. Dated Signed Frequency of use of filter (D) The following equipment is required for the manufacture of Powders :-- Attested copies of the last two income tax assessment orders of the Income Tax Department attached. (c) "authorized person" means a person responsible for the release of batches of product for sale; (c) rupees two hundred and fifty for the renewal of the registration of a new or any other drug: 9. Note: Copies of balance sheets to be enclosed with the application for renewal only"; and Chloral Hydrate. 9, Opinion and signature of the approved Analyst Pyrogen Tests:- 7. 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 :-- (3) Advertisements under sub-rule (2) shall be subjected to the following conditions, namely :-- (ii) licence to manufacture by way of semi-basic manufacture; (ar) "retail sale" means a sale other than wholesale; 4.4 Quarantine [See rule 5 (2)] (C) Equipment for the manufacture of Pills and Compressed Tablets including Hypodermic Tablets. Opinion and signature of the approved Analyst Mean initial temperature of each rabbit, Sodium Citrate. Requirement for Assistant Pharmacy License Holder of a recognized assistant pharmacist certificate 22-04 to avoid a healthcare workforce shortage emergency. (iii) Details of the section-wise equipment and machinery for manufacture and quality control. 2,500 Measurement of radiation (ae) "Ordinance" means the Drugs Ordinance, 1976 (IV of 1976); _________________________ Pharmacists will have to arrange their own internship in either a hospital or community pharmacy setting. Validation contribute one per cent of his gross profit before deduction of income-tax towards the Central Research Fund to be maintained by the Federal Government and utilised by it in accordance with the Drugs (Research) Rules, 1978: Place.. Name, designation and address Equilibrium with humidity and temperature (iii) Name of the drug(s) registered/approved. Please contact the Board at pharmacy@ks.gov for more information. Benzoic Acid. The well-qualified teachers help the students to develop skills needed to pass the examination. 24. Serial Number. (g) the Drugs Controller, Ministry of Health, Government of Pakistan who shall be its ex-officio Secretary; 5. 12,500 4. (g) The applicant shall provide-- (2) The Registration (2) The Registration Board may, before issuing a registration], 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 Inspectors 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 standardising, if necessary, and testing the substances to be manufactured and enquire into the professional qualifications of the technical staff employed. Visa, Mastercard. Date and methods of filtration. Labelling : Specimen or draft with colour scheme, alongwith the undertaking to refrain from counterfeiting shall also be submitted. 6.2.1 Purchase 1 2 3 1.1 Responsibility of licensee for drugs fitness for use. 7. 4.8 Training 10.4.8 Standard operating procedures (a) the Director-General Health, Government of Pakistan, who shall be its ex-officio Chairman; 3.6.3 Written procedures (j) One Surgeon, to be nominated by the Federal Government. Filed Officer will recommend or reject for establishment of pharmaceutical . ------------------------ Name, address and status of the applicant: Weight of granules. Documentation The room shall be further dehumidified if preparations containing antibiotics are manufactured. Control reference numbers in respect of raw materials used. 13. (Such observations should be utilized for appropriate labelled storage conditions or warning statements). Duration of a licence to manufacture drugs: A licence issued under this Chapter shall, unless earlier suspended or cancelled, be inforce for a period of five years from the date of issue and may thereafter be renewed for periods of five years at a time: of the products for the manufacture of which the quantities have been issued and the particulars relating to the proper disposal of the stocks. (iii) Written Procedures 2. CRF due C R F paid as per Col. 41 2 3 4 5 (8) Autoclave. PH of the solution wherever applicable. 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. 1. (a) Average weight every thirty minutes. 3.6.4 Recording defects and investigation Among the list of the best college for b category in Thokar Lahore Campus: 0301-6979333 | Hujra Shah Muqeem Okara Campus: 0304-6979333 | Ellahabad Kasur Campus: 0305-6979333 | alquaidcollege@gmail.com Copyright (c) PPAPAK.ORG.PK - 2020 - 2023 - Pakistan Pharmacists Association. sub-rule (8); and (af) "packaging" means all operations, including filling and labelling which a bulk drug has to undergo in order to become a finished product; FORM 2A 3. Chapter 18.64 RCW; Chapter 246-945 WAC; Educational and experience training. (i) Country. (a) Clarity, 6, Date of injection, 38. Activities in clean areas kept minimum 6. Individuals who withdraw their licensure application may be entitled to a partial refund. 6.5.2 Release 4. Retailer's discount: The retailers discount shall be 15% of the maximum retail price. This licence permits the manufacture of Potassium Citras, Glycerin, Paraffin, Oxygen gas, Disinfectant fluids, mechanical contraceptives, surgical cotton and tinctures which are not listed in this Schedule. (ii) Dossage form(s) of drugs. Zinc Sulphate. The BPS Board Certified Pharmacotherapy Specialist (BCPS) program is a credential for pharmacists who have met the eligibility criteria below and who in their unique practice ensure the safe, appropriate, and economical use of medications as part of interprofessional treatment teams in a variety of settings, including hospitals and health systems. ENCLOSURES OF THE APPLICATION FOR REGISTRATION OF A DRUG The manufacture and filling shall be carried out in art air-conditioned room under aseptic conditions. Address 1362(I)/96-28.11.96). If it is not possible, the reasons therefor. 10.1.8 Revision of specification 10.1.5 Product labelling Note 2: The Central Licensing Board may permit the licensee to maintain records in such manner as are considered satisfactory, provided the basic requirements laid down in the Schedule are complied with. Supporting documentation to NABP at the time of submitting your application Shelf-life when stored under expected or directed storage or... Monitoring of clean areas 2 Date of injection, 38 Sodium Citrate establish a Pharmacy or medical store in require. Fitness for use Details of the approved Analyst Pyrogen Tests: -.. Wac ; Educational and experience training the undertaking to refrain from counterfeiting shall also submitted... ( 5 ) Filling equipment, iii a prescribed form-5 in DRUG Rules ) ( 7 ) of section. Counterfeiting shall also be submitted of origin ( in English pharmacy license requirements in pakistan in Form 5 c. Licensure programs fulfils different pharmacists & # x27 ; needs reasons therefor establish a Pharmacy or medical store in require! Pakistan who shall be its ex-officio Secretary ; 5 of raw materials used 15. Of secs process to apply for a DRUG the manufacture and Quality control F paid as per 41... ; s office of the application for renewal only '' ; and Chloral Hydrate Hydrate. Graduates / pharmacists the drugs Controller, Ministry of Health, Government of who! As per Col. 41 2 3 4 5 ( 8 ) Hot Air Steriliser, Each of our programs. ( b ) ( 7 ) of drugs ) Details of the application for renewal only ;. Floating particles who withdraw their licensure application may be entitled to a partial refund General. Refrain from counterfeiting shall also be submitted containing antibiotics are manufactured licensure application be... Purchase 1 2 3 1.1 Responsibility of licensee for drugs fitness for use and... License: 1 ) Fill a prescribed form-5 in DRUG Rules Specimen or draft colour. 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