Date of Registration Secretary Registration Board (Seal) Chairman. 7.1.7 Unauthorized entry prohibited 12. 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: Quality control 61. FORM 7 Air supply system 3.3.2 Sampling (c) Doors; Doors must be fire resistant preferably with self-closing system, (a) animal or clinical investigations and tests conducted by the manufacturer or reported to him by any person concerning 1. S.R.O. I/We ..of hereby apply for the grant of a licence to manufacture by way ofon premises situated at . and dispensing of drugs established under (b)(7) of this section must be consistent with the requirements of secs. Name and address of the manufacturer Dated (Signed) (k) One physician, to be nominated by the Federal Government; 16. 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. Examination Procedure: 1. Verification can be emailed 3.4 Facilities 3. at least one person holding a degree in pharmacy, medicine, science with chemistry or chemical engineering from a university in Pakistan or any other institution, recognised by the Federal Government for the purposes of the Ordinance, and shall possess qualifications and experience which, in the opinion of the Central Licensing Board, is appropriate and adequate for the manufacture and handling of the drug to be, or being, manufactured. ADDITIONAL CONDITIONS FOR MANUFACTURE OF STERILE PRODUCT (b) The licensee shall record in Schedule B-Ill the particulars of manufacture of each batch of drugs manufactured by him and shall retain such records, in the case of a substance for which expiry date is fixed for a period of two years from the expiry of such date and, in the case of other substances, for a period of five years from the date of manufacture. 12. 57. SECTION--4 35. To LOG IN or CREATE a DELPROS (Delaware Professional Regulation Online Services) user account: Go to: https://delpros.delaware.gov/OH_HomePage. 6.7 Recalled and returned products 2.3 Construction 1. This exam is held 4 times a year 2. General (bb) An applicant for registration of insecticides, pesticides and household disinfectants shall, in addition to the conditions specified in Schedule B and Schedule B-l, comply with the conditions specified in Schedule B-l, A. (2) Granulator. (2) Capsule filling units. Pharmacist Exam and License. 29. Sulphur Sublime. Aspirin and Paracetamol in tablets and liquid forms. For Foreign-trained Pharmacy Graduates / Pharmacists. Pharmacy Technician (Category-B) diploma holder is eligible to apply for license to open own medical store. Substances required to be prescribed under Section 24: Any substance or a mixture of substances offered for sale which is injurious, or likely to become hazardous, to the health of a person shall be deemed to be a substance for the purpose of Section 24 of the Ordinance. 3.4.1 General 2. General Provided that member nominated by a Provincial Government may follow the procedure as laid down for a Provincial Inspector. (5) Mixing tanks for processing medicated dressings. SECTION--2 (6) Sintered glass funnel, seitz filter or filter candle. 7. Licensing Requirements. 20. 9.1 General (d) name of manufacturer or distributor. Equilibrium with humidity and temperature Individuals who withdraw their licensure application may be entitled to a partial refund. (i) enclose certificate of registration and Free Sale from any of the following countries: (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). 7.3.3 Defective equipment 3.5 Quality Audit 4.9.6 Appropriate clothing and covering I/We . of hereby apply for the renewal of a licence to manufacture by way of on premises situated at Records of readings taken to check weight variation in case of capsules, CONDITIONS FOR GRANT OF A LICENSE TO MANUFACTURE BY WAY OF FORMULATION 5.1 Sanitation 1. Committee on Safety of Medicines of U.K. or corresponding agencies of France, West Germany, Japan, Sweden. Proposed shelf life with storage conditions, if any : Antitoxins. (v) high standard of personnel hygiene shall be observed by all persons concerned with production processes, and Super Easy Way to Start Pharmacy Business in Pakistan! Cough Preparations. 4.1 General Use of disinfectants and detergents 4.10 S.O.Ps Miscellaneous In case of a new drug (entity) not yet registered in Pakistan : Date of receipt of sample, (6) Antacid and carminatives: The well-qualified teachers help the students to develop skills needed to pass the examination. [Omitted vide S.R.O. Local exhaust system must be effective,. [See rule 2 (e)] 56. and Denmark. Copyright (c) PPAPAK.ORG.PK - 2020 - 2023 - Pakistan Pharmacists Association. Magnesium Sulphate. 6.10.2 Disposal 6.2.10 Checking Interval between operations to be minimal Additional conditions of licence to manufacture drugs by way of formulation: A licence to manufacture drugs by way of formulation shall, in addition to the conditions laid down in rule 19, be subject to the following further conditions, namely :-- Brights disease, cataract, glaucoma, epilepsy, [] lacomotive ataxia, multiple sclerosis, lupus, paralysis, blindness. Licence to manufacture drugs by way of repacking: (1) A licence to manufacture drugs by way of repacking is required for the repacking of such drugs, and under such conditions, as are specified in Schedule D. The following equipment required :- (ax) "standard operating procedure" means an authorized written procedure indicating instructions for performing operations not necessarily specific to a given product or material but of a more general nature such as equipment operation, maintenance and cleaning validation, cleaning of premises and environmental control sampling and inspection, and certain standard operating procedures may be used to supplement product specific master and batch production documentation; 7. Male Female . 2.4 Products manufactured under aseptic conditions Potassium Citras, Glycerin, Paraffin, Oxygen gas, Disinfectant fluids, mechanical contraceptives, surgical cotton and tinctures which are not listed in this Schedule. 11. 3.7 Product recalls (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. Pay your fees using internationally accredited credit cards e.g. Ferric Ammonium Citrate. (ii) diminish the risks, inherent in any pharmaceutical production, including contamination, cross contamination and mix ups (confusion) that cannot be detected completely through the testing of final products; (d) Sterilisation. (2) The Registration Board may refer any case for detailed .examination to the committee of experts on the Drugs Evaluation constituted under Section 10 of the Act. 1.1 Responsibility of licensee for drugs fitness for use. (i) if the application for renewal is made before the expiry of the validity of a certificate Rs. 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. (iii) Surfaces (6) A licensee who for any purpose is engaged in the culture or manipulation of pathogenic spore bearing micro-organisms shall provide, to the satisfaction of the Central Licensing Board, separate laboratories, utensils and apparatus required for the culture or manipulation of such .micro-organisms, and they shall not be used for the manufacture of any other substance. criteria. 6.3.4 Obsolete materials 22. 6.5.1 Quarantine (az) "system" means a regulated pattern of interacting activities and techniques which are united to form an organized whole; Records in respect of each raw material shall be maintained indicating the quantity received, control reference numbers, the quantities issued from time to time, the names and batch Nos. 1.6 In the case of contract analysis, the final approval for release must be given by the authorised person(s). 6.2.4 Damaged container (v) Storage (1) Rolling machine. Provided that: Any individual, LLP, partnership firm, OPC or company can apply for a drug license. Name of the drug, Care for biological indicators (8) Contraceptives. (4) Folding and pressing machine for gauze. 6.10.1 Storage (iv) adequate precautions for safe-guarding the health of the workers, including measures to avoid industrial accidents or diseases. 15. [Omitted vide S.R.O. (i) Particulars regarding the legal status of the applicant (i.e. Calcium Gluconate. Eliminate fibers D. Raw materials: Name of all ingredients, quantities required for the batch size, quantities actually used. Name of the sample. 21. 14. 4. Pharmacy Miscellaneous Permit (Out-Of-State Pharmacies) License. 3, Batch number FORM 3 Sodium Bromide. FORM 2A 20. Entertainment or other hospitality, offered to members of the medical and allied professions shall be secondary to the main purpose of the meeting and shall be kept to a modest level. (d) The applicant shall establish an independent Quality Control Department and maintain separate staff, premises and adequate laboratory equipment for carrying out tests of the strength, potency, quality and purity of the substances being or to be used in the manufacture. Opinion and signature of the approved Analyst. 4.8.3 Specific training We recommend that you send all supporting documentation to NABP at the time of submitting your application. FORM 2 Panamanian domestic regulations also require that the . 3.7.9 All concerned to be informed Fumigation (b) the labelling; 5.3 General Requirements for Production Areas If withdrawn from the market anywhere (3) If the application for renewal of the licence is made after the expiry of the period of the validity of the licence, it shall be treated as a fresh application for the grant of a licence. Name of the Company .Type of ownership (Partnership, Proprietorship, Public limited, Private limited, etc.) (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: (1) Mixing and blending equipment. 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: (All weighings and measurements shall be checked initiated b the competent person in the section). Form 1 2.8 Defective Equipment (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 Validation (9) If the Registration Board is not satisfied as to the safety, efficacy, quality or economic value of a drug, or where the public interest so requires it may, [ . Chapter 18.64 RCW; Chapter 246-945 WAC; Educational and experience training. 1500 Hours of Experience. 6. 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. Batch number. 10.4.8 Standard operating procedures Any wording and illustration on the package and label shall conform to the principles of ethical criteria enunciated in this Schedule. Information on price to the consumer shall be accurately and honestly portrayed. One must pass this exam to be registered as pharmacist. in force for a period of five years from the date of Registration of the drug and may thereafter be renewed for periods not exceeding 5 years at a time. 15. 14. Use of protective garments 13. 11. 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. Finishing of sterile products (8) Jar or tube filling equipment, where applicable. Sulphonilamide Powder (B. VET. B.S. Sanitation Use of vacuum (2) Analgesic Balms/Plasters. (d) the approved therapeutic uses; Procedure for registration: (1) The Registration Board may, if it considers necessary, cause the application for registration and the information and material supplied to it under rule 26 to be evaluated by a Committee on Drugs Evaluation consisting of experts related to the aspect of the drug to be evaluated and obtain its report. Note I: The foregoing provisions represent the minimum requirements to be complied with by the licensee. For efficient operation, the tablet production department shall be divided into the following three distinct and separate sections situated in different rooms, 08.80.040 . Advertisements in any form made to physicians and health-related professionals.-(1) The wording and illustrations in advertisements to physicians and related health professionals shall be fully consistent with the approved scientific data sheet for the drug concerned or other source of information with similar content. (2) Kettles, steam, gas or electrically heated. 4.6 Packaging Instructions (2) If any drug manufactured for experimental purposes is supplied by the manufacturer to any other person, the container shall bear a label on which shall be stated the name and address of the manufacturer, the accepted scientific name of the drug, if known, or, if not known, a reference which will enable the drug to be identified and the purpose for which it has been manufactured. 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. Calcium Hydroxide. (e) Disintegration test (time in minutes). 2. Date of commencement of manufacture and date when manufecture was completed, 10.1.9 Packaging material specification Pharmacy Intern Permit. 20. Washing of clothing Maintenance of clean area 7. (A) For the grant of Registration Rs. Manufacturing Area : (a) recommended clinical use and the claim to be made for the drug. 7.3 Processing operations intermediate and bulk products 6.2.5 Delivery from different batches Certified that following drug(s) are hereby registered under the Drugs Ordinance/Act, 1976:- HTML PDF: . Captcha: 9 + 4 = Sign In. The walls and floor shall be such as may permit their being sprayed and washed with an antiseptic solution. Proposed dosage : Precautions against contamination Calamine. 22. (i) Class(es) of drugs. Once approved, the agency will schedule a site inspection. Prohibitions Records of test to be carried out in case of tablets as under 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. Harrisburg, PA 17105-2649. Form-5 (Click to Download) 2) Fill an affidavit on Rs. Particulars regarding the precautions taken during manufacture to ensure that aseptic conditions are maintained. (9) The licensee shall allow any member of the Central Licensing "Board or of a Provincial Quality Control Board of an Inspector to inspect all registers and records maintained under these rules and to take samples of the manufactured drugs and shall supply to such member or Inspector such information as he may require for the purpose of ascertaining whether the provisions of the Ordinance and the rules have been observed. Dose and volume of solution injected into each rabbit and time of injection. Contract Manufacture.-- Manufacture or analysis on contract is permissible on behalf of a licensee or of a pharmaceutical company whose products are registered in Pakistan for sale subject to the conditions laid down in Schedule G," as a special case and for genuine reasons as approved by the Registration Board. (bb) "wholesale" means sale to a person who purchases for the purpose of selling again and includes sale to a hospital or dispensary, or to medical, educational or research institute. Form-7 License: This type of Drug sales license should be used for the sales of Medicines for Importers, Exporters, Indentors and Manufacturers. Handling procedures 6.5 Finished Pharmaceutical Products (e) The Quality Control Department shall be independent of the manufacturing unit and its incharge shall be 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 or pharmacology (for pharmacological testing) or a degree in microbiology (for microbiological testing) and has sufficient experience in testing of drugs: (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. Records of the disposal of rejected batch and batches with-drawn from the market. Name of the drug: 2. Licensing requirements for Michigan healthcare and pharmaceutical companies and individuals. 7.1.2 Material handling Inspection of containers (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. This registration shall be valid for a period of five years unless earlier suspended or cancelled. 4.2 Design 1. 7.4.2 Pre-packaging checks 2 Examinations. Pharmacy Technician Registration Requirements & Application (online application) of tablets, injections tubes litres etc. By way of basic Rs. Bio-availability, Bio-equivalence and Pharmacokinetics Analysis (For Dosage Form Introducing first time in Pakistan). Magnesium Trisilicate. (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; 10.1.3 Documentation system HTML PDF: 246-945-235: Nonresident pharmacy license. 5. 4.8 Packaging Materials (1) Hot air oven electrically heated with thermostatic control. Toxicity Test: Venereal diseases. If you have an active intern registration in Kansas, you may only need to pay $100. Liquid Paraffin Heavy. An area of minimum of 200 square feet is required for the basic installations. (8) In respect of new drug, records, including adequately organised and indexed files, shall be maintained containing full information regarding-- 6.1 Material, general [See rule 31 (10)] . Board shall be deemed to be an additional category of drug for the purpose of this Schedule. sub-rule (8); and [See rule 26(I)] (5) The meetings of the Central Licensing Board may be held at such time as the Board may deem fit and, on the request of any of its members, the Chairman may at any time call a meeting if there is any important matter for its consideration. Documentation 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. (iii) Written Procedures As a first step, your business must obtain a resident or in-state pharmacy license from your state's licensing agency. (iii) Cost of direct labour, Sulphur Precipitated. The License can be renewed as it is valid for up to five years. 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Public limited, Private limited, Private limited, Private limited, etc )! ) Disintegration test ( time in minutes ) from the market the claim to be complied with by licensee.