2. 536(1)/93 dated 23rd June 1993. Certificate regarding sale and G.M.P. 9.2.2 Validation of new master formula Sodium Iodide. 4, Date of receipt of sample Degree or. 1.1 Responsibility of licensee for drugs fitness for use. Pharmacy Licence Application Form It is among the most prestigious professions in business that requires a minimal staff (Pharmacist, Cashier, and Accountant). Pharmacy Miscellaneous Permit (Out-Of-State Pharmacies) License. Composition of the drug stating quantity of each active and non-active ingredients per unit dose or percentage of total formulation: 10.1.3 Documentation system 5. 10. (15) The licensee shall, on or before the 31st July each year, submit a duly Signed profit and loss statement as per "PROFORMA" given in FORM-1 of SCHEDULE-A alongwith an evidence of deposit of 1 per cent of profit towards the Central Research Fund; Manufacture of sterile preparations 6.5 Finished Pharmaceutical Products 2.5 Tanks 6.5.2 Release There are two dispensing licenses offered by the Board of Pharmacy as outlined in guidance document 110-29. 6.3.4 Obsolete materials B. Parenteral preparation: [See rule (5(I)] (ay) "starting material" means any substance used in the production of a pharmaceutical product but excluding packaging materials; 10.1.1 Maintenance of documents 21. 17. 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. Countersigned by .. (ap) "recovery or blending" means the introduction of all or part of previous batches, or of redistilled solvents and similar products, of the required quality into another batch at a defined stage of manufacture; 2,500 31. An area of minimum of 200 square feet is required for the basic installations. Pack size. The following basic hygienic requirement shall be complied with (f) the applicant shall ensure that-- Phone - (717) 783-7156. 6.9.4 Storage GOVERNMENT OF PAKISTAN Personnel: To void intoxication by skin contact, inhalation of fumes, vapours and dust, accidental ingestion, the protected clothing and equipments, e.g., protective helmet or cloth cap, eye protection (safety spectacles, goggles or face shield) dust or light fume masks, one piece worksuit with closely fitting trouser bottoms, rubber or plastic gloves Or gauntlets, rubber or plastic apron, and workboots with protective toecaps, must be provided. (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. (3) Advertisements under sub-rule (2) shall be subjected to the following conditions, namely :-- 2. (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; Inspection of containers (b) children by age group. (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. (3-B) Any application under sub-rule (1) or sub-rule (3) shall be accompanied by the proper fee specified in Schedule F. (b) To check the presence of foreign particles. 9. 10 Major Steps And Requirements To Open Your Independent Pharmacy 1. (4) Folding and pressing machine for gauze. SCHEDULE E SECTION -- 7 7.4.8 On-line packaging checks FORM 2 (d) "basic manufacture" means manufacture of a drug from basic raw material to a product which is ready for use as a starting material for the formulation of a finished drug or for repacking and such manufacture may involve chemical, bio-chemical, photochemical, microbial or such other processes or a combination of any of such processes; 3.7.5 Distribution records 1. 1.Analytical report number This room shall be air-conditioned. (2) Coating pan. 6.7.2 Returned goods (1) Mixing and storage tanks. 14. Invoice/Challan number and date. 3.6.6 Follow-up action FORM 6 Promotion of drugs.- (1) For the purposes of this Schedule, "promotion" means all informational and persuasive activities by manufacturer and distributors, the effect of which is to induce the prescription, supply, purchase and/or use of medicinal drugs. . 2. 29. Pharmacological and clinical data : FORM 3 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. Location and surrounding: The premises should be away from drinking water sources and an area liable to flooding. Fumigation The checks should be carried .out by a properly equipped hospital or laboratory under qualified expert. 18. 1.6 In the case of contract analysis, the final approval for release must be given by the authorised person(s). To verify a wholesale drug distributor is licensed in the state (s) where it is. In package inserts or leaflets the manufacturers or distributors shall ensure that the information reflected is correct. Iodine. The contract (2) An application under sub-rule (1) shall be accompanied by the proper fee as specified in Schedule F. 14. (2) An application under sub-rule (1) shall be countersigned by the head of the institution in which,. Promotion in the form of financial or material benefits shall not be offered to or sought by health care practitioners to influence them in the prescription of drugs. Stability studies : 3. (7) A new drug, where new method of manufacture is contemplated or a change is proposed in source, standard or specification of the active ingredient or the finished product, may not require full investigations and clinical trials except in so far as they are necessary for the purpose of establishing bio-equivalence, absorption, acceptability or other such features. 6.2.7 Identity of contents I/We .. of .. hereby apply for renewal of registration of the drug, namely ..details of which are as follows (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; 25,000 Batch number. Signature of the expert staff responsible for the manufacture, Provided that under special circumstances to be recorded in writing, the Registration Board may register a drug and require such investigations and clinical trials to be conducted after its registration. 7.3.8 Equipment calibration 20. Equilibrium with humidity and temperature Central Licensing Board: (1) The Central Licensing Board shall consist of the following members, namely :-- (i) the claims to be made for the drug; 10. The application fee is $147. (8) Hot Air Steriliser, Sampling of drugs: Samples of drugs may be provided to the physicians or dentists or Pharmacists or Veterinarians or a medical institution in a reasonable quantity and in reduced packings marked with the words "Physicians Sample Not for Sale". Serial Number. 26. SECTION--2 9. 9. 2. of USA. (i) Class(es) of drugs. (3) If a person possesses, or applies for, more than one type of licences to manufacture drugs in the same premises, he may establish one Quality Control Department for the purpose of both the licences. 551(1)//93, dated 3. 16. Amenorrhoea metrorrhagia, memorthagia, metrosalpingitis, ovaritis, fibromas, cysts. (au) "Schedule" means Schedule to these rules; 10.4.3 Recording packaging operation 9. Application fee for Advertisement. (h) any unexpected side effects, injury, toxicity or sensitivity reaction associated with the clinical uses, studies, investigations and tests respecting that drug; and Researching legal requirements is an important step in learning how to open a pharmacy, and you want to ensure that you have everything properly set-up before opening your business. (4) Every drug shall be produced in sufficient quantity so as to ensure its regular and adequate supply in the market. Labelling : (Specimen to be enclosed alongwith a .sample and undertaking to refrain from counterfeiting shall also be submitted) : Methyl Salicylate. 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: (6) Finished products shall be stored in a suitable separate place. Address. Licensing requirements for Michigan healthcare and pharmaceutical companies and individuals. Both are non-refundable. How to get a pharmacy license in Pakistan? (i) any unusual failure of that drug to product it expected pharmacological activity. Name of the registered drug, with its registration number and date or initial ,registration and last renewal ' SECTION -- 10 Sodium Thiosulphate. 4. In case, the pharmacy business combines retail and wholesale, a minimum of 15 square meters is required. 2. (4) The licensee shall maintain in the inspection book provided by the Central Licensing Board at the time of the issuance of the licence on which a member of the said Board or of a Provincial Quality Control Board or an Inspector shall record proceedings of each of his visits, his impressions and the defect or irregularities noticed, if any, by him and such inspection book shall be signed by him as well as the licensee or his authorised agent. 6.1 Rest Rooms (4) A licensee whose licence has been cancelled or suspended may appeal to the Appellate Board within sixty days of the date of receipt of the decision of the Central Licensing Board by the licensee and until the Appellate Board has given its order, the licence shall remain cancelled or suspended, as the case may be. Name of the Firm. Control reference numbers in respect of raw materials used. 2.8 Defective Equipment Perform location analysis 3. First submit an application Central Licensing Board for establishment of a pharmaceutical unit. Form-7 License: This type of Drug sales license should be used for the sales of Medicines for Importers, Exporters, Indentors and Manufacturers. (6) in. Date .. 7. 2. 7.2.2 Measures against contamination The drug(s) or class(es) of drugs intended to be manufactured :- FEE FOR ADVERTISEMENT 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: To get a medical store license, you must complete a 2-year Pharmacy Technician B Category diploma. (Seal) Chairman, Central Licensing Board. 12. Fax - (717) 787-7769. (j) Cost Accountant of the Ministry of Health; Signature of Analyst, 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. 4. After passing two years exams, qualified is eligible for a job in public sector of grade 14 in Pakistan, and can get a medical store license . 2. 2. (ii) unhygienic practices eating and smoking shall not take place in any production or quality control area; (a) The generic name(s) of the active ingredient(s); Calcium Carbonate. 16. 37. Control reference numbers in respect of raw materials used in formulation. Promotional material shall not be designed so as to disguise its real nature. 8. 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. (a) For the grant of licence: (a) for adults. New processes to be validated (b) immediately upon receipt by him, reports in duplicate of all records respecting the information contemplated by paragraphs (d), (e) and (f) of sub-rule (8); and (a) adequate space and equipment shall be provided; Phenothlazine (B. VET. ---------------- (i) 62. (5-A) Where the Registration Board registers a new drug, it may recommend to the Federal Government for fixation of maximum price of such drug. 3, Batch number (c) the statement of all the representations to be made for the promotion of the drug in respect of-- General 55. Signature of the expert staff responsible for manufacture. Protective garments in grade B room Substances Parenteral preparation in general: Total. (a) Clarity, By way of basic Rs. 10.1.9 Packaging material specification (vi) Environmental Controls MATERIALS (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; 2. (c) if any adverse drug reaction not otherwise included in the application for registration, is registration, is registered in any of the said countries, it shall be the responsibility of the concerned manufacturer or in case of imported drugs the indentor or manufacturer's agent in Pakistan, to be aware of such adverse action and to report to the Registration Board within thirty days of becoming so aware. Response. LICENCE TO MANUFACTURE DRUG(S) Sterility test reference on bulk batch wherever applicable. (iv) the contra-indications, the side effects and precautions if any; and REQUIREMENTS OF PLANT AND EQUIPMENT General Process to apply for a Drug sales License: 1) Fill a prescribed form-5 in Drug Rules. 5.1 Sanitation Labeling of drugs manufactured for experimental purposes: (l) Any d-rug manufactured for experimental purposes shall be kept in containers bearing labels indicating the purpose for which it has been manufactured. Serial number Licence to Manufacture 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. (5) Mixing and storage tanks of stainless steel or of other suitable material. is/are hereby licensed to manufacture by way of Basic Manufacture/Semi Basic manufacture/Formulation/Repacking at the following premises:- Type of licence Fee Employers shall be responsible for the basic and continuing training of their representatives. 277 (1)/96 dated 2 lst April 1996. 16, Records on the disposal of rejected batches and batches with-drawn from the market. It is an exam to acquire a license for all medical professionals who would like to work in Dubai. (b) the Director, Health Services of, each Provincial Government; 5,000 4.1 A contract shall be drawn up between the contract giver and contract acceptor that specifies their respective responsibilities relating to the manufacture and control of the product, and technical aspects of the contract shall be drawn up by competent persons suitably knowledgeable in pharmaceutical technology, analysis, and good manufacturing practices. General Biological indicators I/We ..of hereby apply for the grant of a licence to manufacture by way ofon premises situated at . (5) Any fee deposited under sub-rule (2) Shall in no case be refunded. (4) Antidandruff preparations. 6 wherever necessary. 3. 12. Requirement for Pharmacist License Must hold a pharmacy certificate from a recognized high institute, college or university. In the case of operations involving floating particles of fine powder or dust, a suitable exhaust system should be provided. Advertisements shall also indicate, where applicable, appropriate limitations to the use of the drug. 3, Batch Size, 6. 2.3 Construction Workers should not be exposed again to cholinesterase inhibiting compounds until further tests show a blood cholinesterase activity within 20% of the pre-exposure value. 5. 6.5.1 Quarantine Storage Areas PH of the solution wherever applicable. 5. 9. Date of release finished packings for distribution or sale. (s) "formulation" means all operations involved in converting a drug into a final pharmaceutical dosage form ready for use as a finished drug including compounding, processing, formulating, filling, packing, finishing, labelling and other like processes; 9.2 Process validation Castor Oil. DOCUMENTATION Medical representative shall not offer inducements to prescribers and dispensers. sub-rule (8); and 13. (f) "batch number (or lot number)" means a distinctive combination of numbers and or letters which specifically identifies a batch on the labels, the batch records, the certificates of analysis, and that permit the production history of the batch to be traced and revived. 40. Care for biological indicators Protocols of tests applied: The scheduled narcotic and psychotropic drugs shall not be advertised to the general public in connection with fight against drug addiction and dependency. Name of Indenter/Manufacturer's agent/Importer (in case of imported drugs only). (11) Reminder publications for the medical, pharmaceutical and allied professions shall include the name of the drug and its exact composition, the price, the name and address of the manufacturer and a statement to the effect that "Full information is available on request". Secretary, Central Licensing Board. Sterilization by ethylene oxide CONDITIONS OF FACTORY PREMISES Suitability of process [See rule 26 (1)] 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. 9. 2. 63. 6.2 Starting materials Pack size (s) and proposed maximum retail price with the following details:- 4. Packaging and labelling.- Appropriate information being important to ensure the rational use of drugs, all packaging and labelling material shall provide information consistent with that approved by the Registration Board and if no such approval is available it shall be, consistent with that approved by the drug regulatory authority of the country from which the drug is imported or other reliable sources of information with similar content. {4) Heater and exhaust system, where applicable. Any wording and illustration on the package and label shall conform to the principles of ethical criteria enunciated in this Schedule. (iii) any foreign qualification the quality and content of the training of which are comparable with those described in sub-clause (i) or sub-clause (ii) and is approved for the purposes, of this sub-rule by the Central Licensing Board: Provided that the Central Licensing Board may, in the case of manufacture of drugs included in Schedule C, permit the manufacture of such drugs under the active direction and personal supervision or a person holding a degree in medicine or veterinary sciences of a university in Pakistan or any other institution recognised by the Federal Government, with at least three years experience in the manufacture, testing and analysis of biological products which are intended to be produced: C). Comparison of products shall be factual, fair and capable of substantiation. 2. 7. 14. 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. Prescription drugs should only be purchased from wholesale drug distributors licensed in the United States. DISEASES, ADVERTISEMENT FOR TREATMENT OF 6.10.2 Disposal 2. (iv) adequate precautions for safe-guarding the health of the workers, including measures to avoid industrial accidents or diseases. Conditions of licence to manufacture, by way of basic manufacture, semi-basic manufacture formulation and repacking of drugs: (1) A licence to manufacture by way of basic, semi-basic manufacture, formulation or repacking of drugs shall be subject to the conditions stated herein, if any, and to the further condition that the licensee shall continue to maintain conditions on the basis of which he was granted a licence. 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. 3.4 Facilities (2) The import, manufacture and sale of drugs shall be in accordance with the information contained in the applications in respect of those drugs or in any supplementary information or, where such information was amended by the Registration Board, in accordance with such amended information on the basis of which such drugs were registered: 4.8.3 Specific training 7.3.6 Product pipelines SECTION--2 (i) licence to manufacture by way of basic manufacture. (viii) Light (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. PARTICULARS TO BE RECORDED IN THE ANALYTICAL RECORDS Name(s) of the drug(s): 10.4.8 Standard operating procedures I/We of ..hereby apply for registration of the drug, namely..details of which are enclosed. Sodium Potassium Tartrate. : 3.5 Quality Audit 8. (e) any error in the labelling of that drug; Learn More Continuing Education Provider Accreditation Click to learn more about: CE Provider Accreditation (i) Granulating Section; Pharmacy Technician Registration Requirements & Application (online application) Antitoxins. Processing 4.6 Duties of Production Incharges
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