pharmacy license requirements in pakistan
_________________________ Procaine Hydro-Chloride. [See rule 5 (/)] 4.3 The contract shall be describe clearly who is responsible for purchasing, testing and releasing materials and for undertaking production and quality controls, including in-process controls, and who has responsibility for sampling and analysis, and in the case of contract analysis, the contract shall state whether or not the contract acceptor shall take samples at the premises of the manufacturer. Quality assurance system. 5,000 (9) No drug or any other substance shall be advertised in a manner which encourages self-medication or use to the extent that it endangers health. APPLICATION FOR LlCENCE TO MANUFACTURE DRUG(S) FOR EXPERIMENTAL PURPOSES. (6) If after the expiry of three months but within six months of the rejection of an application under sub-rule (4), the applicant informs the Central Licensing Board that the requirements of the rules have been fulfilled, the Board may if after causing a further inspection to be made, is satisfied that the conditions for the grant of a licence have been complied with, issue a licence and no further fee shall be required to be deposited for such an application. 10,000 6.2.6 Labelling (g) precautions, contra-indications and warnings; 4. Certificate of registration: A certificate of registration of drug shall be issued in Form 6. (d) the approved therapeutic uses; 50.00 stamp papers as prescribed ( Click to Download- Affidavit) SECTION -1 (ag) "packaging material" means any material, including printed material, employed in the packaging of a pharmaceutical product, excluding any outer packaging used for transportation or shipment and packaging materials are referred to as primary or secondary according to whether or not they are intended to be in direct contact with the product; (a) recommended clinical use and the claim to be made for the drug. They shall be adequately trained so as to posses sufficient medical and technical knowledge and integrity to present information on products and carry out other promotional activities in an accurate and responsible manner. Sufficient time allowed to reach required temperature We offer Coaching for Healthcare professionals under the guidance of well experienced professional trainers. (a) The generic name(s) of the active ingredient(s); 18. 22. (j) One Surgeon, to be nominated by the Federal Government. (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; Fax - (717) 787-7769. 3.4.4 Frequency of self inspection (i) "biological agents" means micro-organisms, including genetically engineered micro-organisms, cell cultures and endoparasites, whether pathogenic or not; (2) A drug or any substance referred to in clause (ii) of Sec. State Board of Pharmacy. (iv) adequate precautions for safe-guarding the health of the workers, including measures to avoid industrial accidents or diseases. Free samples of prescription drugs for promotional purposes.- Free samples of drugs may be provided in modest quantities to prescribers, preferably on request. Record maintenance (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. (10) No drug or any remedy, treatment or after treatment of any disease specified in Schedule 'E' shall be advertised except as provided in sub-rule (2). 6.2.9 Correct dispensing (a) Generic/international non-proprietary name: Copyright (c) PPAPAK.ORG.PK - 2020 - 2023 - Pakistan Pharmacists Association. pharmacist registration renewal process in india. If package inserts or leaflets are used for promotional purposes, they shall comply with the ethical criteria enunciated in this Schedule. Conditions for Advertising: (1) The Federal Government may, after seeking advice of the Committee on Advertising, allow the advertisement of a drug, or any substance or a remedy as specified in Schedule D-1 or a treatment or offer of a treatment for any disease. 5.3 General Requirements for Production Areas Employers shall be responsible for the basic and continuing training of their representatives. Processing Provided that: Once you determine where you wish to practice pharmacy, you will apply for a license through the respective State Board of Pharmacy. Name of the drug. The fees for submitting your application include an application fee ($100) and an evaluation fee ($450). wherever necessary III. CONDITIONS FOR GRANT OF A LICENSE TO MANUFACTURE BY WAY OF FORMULATION (iii) Specifications (All weighings and measurements shall be checked initiated b the competent person in the section). (2) Medical representatives shall make available to prescribers and dispensers complete and unbiased information for each product discussed, such as an approved scientific data or other source of information with similar contents. (ii) licence to manufacture by way of semi-basic manufacture; Pharmacy Licence Application Form It is among the most prestigious professions in business that requires a minimal staff (Pharmacist, Cashier, and Accountant). criteria. 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: 4.4 Prohibition of unauthorized person 25. Borax. (2) When lay language is used the information shall be consistent with the approved scientific data or other legally determined scientific basis for approval. 4. 15,000 (e) The Quality Control Department shall be independent of the manufacturing units and its incharge shall be a whole-time employee of the manufacturer and shall possess a degree in pharmacy, or a degree in science with chemistry, or a degree in medicine, microbiology, pharmacology, or bacteriology from a university in Pakistan or any other institution recognised by the Federal Government for the purposes of Ordinance, as the Central Licensing Board may deem fit for any particular unit; and shall be independent of the incharge of the manufacture (Production Units). 7.3.9 Repair or maintenance {4) Heater and exhaust system, where applicable. (1) Strict sanitation shall be maintained throughout the entire plant in order to prevent contamination and to keep out pyrogens, Masks end overalls shall be worn wherever necessary. Monitoring water supply of sources prevent, the entry of air from outside. (j) "bulk product" means any product that has completed all processing stages up to, but not including, final packaging; Batch number. Application for licence to manufacture drugs and fee therefor: (1) An application for the grant or renewal of a licence referred to in clauses (i) to (iv) of rule 3 shall be made in Form 1 or l-A to the Central Licensing Board addressed to its Secretary. Benzoic Acid. Name of the manufacturer/supplier. 2. [See rule 17(1)] (i) A decease of more than 20% in blood cholinesterase activity,. (14) Leak tasting equipment. (h) any unexpected side effects, injury, toxicity or sensitivity reaction associated with the clinical uses, studies, investigations and tests respecting that drug; and Duration: 2 years, annual system, NTS based examination Eligibility: Male Female . (3) Any change in the expert staff or significant alteration in the licensed premises or equipment shall be immediately notified to the Central Licensing Board. 4.1 Capacity 5. 21. that drug; 11. Pituitary (Posterior Lobe) Extract. (e) Type of container/package, with the nature of material, package testing (chemical, mechanical, environmental). Provided further that a person already approved by the Central Licensing Board as the production incharge of a pharmaceutical firm shall continue to be the technical supervisor of that firm for the purposes of this rule. Select correct technology 9. in Pharmacy. (d) one pharmacist, to be nominated by the Federal Government; Design website 8. 9.1 General Name of all ingredients, quantities required for the batch size, quantities actually used. Sterilization by heat Potassium Iodine. 15. or PharmD) is required to sit for the North American Pharmacist Licensure Examination (NAPLEX). 51. 3.4.6 Follow-up Action (2) Stainless steel scoops end vessels. (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 (ii) Dossage form(s) of drugs. (aw) "specification" means the requirements with which the products or materials used or obtained during manufacture must conform as specified in the Drugs (Specification) Rules, 1978; 9. 3. It is certified : Filter safety 7. 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! (1) Tablet machine, single punch or rotary. This exam is held 4 times a year 2. Licence to Manufacture (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. (n) "consignment or delivery" means the quantity of starting material or of a drug product, made by one manufacturer and supplied one time in response to a particular request or order, a consignment may comprise one or more packages or containers and may include material belonging to more than one batch; (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; (r) "Form" means a form set forth in Schedule A; Sterilized surgical lignature and sterilized surgical suture. (14) The Licensee shall , by the 30th June and the 31st December each year, Whichever is immediately after the annual financial closing of the company. 16. (i) Number of mice used and weight of each mouse, Strength and volume of the drug injected, (i) Equipment (1) Jacketed kettle, or equivalent steam, gas or dect1cally heated for preparing solution. (4) The Registration Board may appoint a panel of experts or inspectors to inspect on behalf of the Board the premises of a manufacturer of drugs and to submit its report to the Board. I/We of ..hereby apply for registration of the drug, namely..details of which are enclosed. and Fumigation Our licensure programs align with board of pharmacy requirements and streamline processes for pharmacists, technicians, interns, and seeking to practice in additional states, whether it is permanent or in response to a public health emergency. Comparison of products shall be factual, fair and capable of substantiation. Although health education aimed at children is highly desirable, drug advertisements shall not be directed at children. WHICH IS PROHIBITED MANUFACTURE BY WAY OF FORMULATION Pharm.D. Aseptic Filling and sealing room: 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. Name of drug, under which it is proposed to be sod: (7-A) The indenter, importer or manufacturer's authorised agent shall issue a warranty in Form 2-A for any drug indented or sold by him for the purpose of re-sale or distribution; and (K) Requirements for the manufacture of Parenteral Preparations: The whole process of the manufacture of parenteral preparations may be divided into the following separate operations: SCHEDULE A (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. Pharmd ) is required to sit for the North American pharmacist Licensure Examination ( NAPLEX.! Required temperature We offer Coaching for Healthcare professionals under the guidance of well experienced trainers. $ 100 ) and an evaluation fee ( $ 100 ) and an evaluation fee $! ) Generic/international non-proprietary name: Copyright ( c ) PPAPAK.ORG.PK - 2020 2023... 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