Drug Manufacturing License; Medical Devices Establishment Licenses; Alternative Medicines & Health Products Establishments; Application Process; Good Practices Compliances (GxP) . 2. 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. The Registration Board after getting the said intimation shall take similar action for the same drug available from other sources within the shortest possible time; Checking integrity of filters 1500 Hours of Experience. (2) When lay language is used the information shall be consistent with the approved scientific data or other legally determined scientific basis for approval. Pharmacy Technician (Category-B) diploma holder is eligible to apply for license to open own medical store. Whether the drug is registered for local manufacture or import 1. Collaborate with a contractor 6. Location and Surroundings . 8. Analytical report number. 3.3.7 Stability studies No. 1. (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. D. Raw materials: (a) Clarity, FORM 3 10.4.1 General 08.80.040 . Captcha: 9 + 4 = Sign In. Provided that in the circumstances beyond the control of a manufacturer,, of a drug which may lead to reduction in the production of that drug, the circumstances may be intimated to the Registration Board. how to apply dha exam for pharmacist. 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! 3.3.4 Test requirement for in-process controls (b) the content of active ingredient(s) per dosage form or regimen; (5) A drug or any substance referred to in clause (ii) of Section 24, may be advertised to the medical, pharmaceutical and allied professions through a documentary film. In case, the pharmacy business combines retail and wholesale, a minimum of 15 square meters is required. 15. The walls and floor shall be such as may permit their being sprayed and washed with an antiseptic solution. Provided further that duration of a licence issued under rule 21 shall be two years unless earlier suspended or cancelled. 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. SECTION -- 7 Sexual importance. Disciplinary and criminal history for owners and officers of the pharmacy. 59. Pharmacy exam: Questions will cover broadly most area of pharmacy, clinical, pharmacology, therapeutics, pharmacy calculations, over the counter medicines and patient counseling 1.1 Contract of manufacture shall be undertaken only by a manufacturer who hold a valid drug manufacturing license, and the contract acceptor shall/have adequate facilities, knowledge, experience and competent personnel to satisfactorily carry out the work ordered by the contract giver. (c) Recommended storage conditions and expiration date to be assigned to the specific formulation and package.. Ancillary Areas Comparison of products shall be factual, fair and capable of substantiation. 8. (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; Note /: The above requirements of this schedule are subject to modifications, at the discretion of the Central Licensing Board if it is of the opinion that having regard to the nature and extent of the manufacturing operations it is necessary to relax or alter in the circumstances of a particular case: An area of minimum of 250 square feet is required for the basic installation. (d) any directions for the use to be included in the labelling, warning and precautions in use : symptoms of over dosage should be given alongwith the treatment including antidotes, where required. (4) Water still or Deioniser. (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. Name of drug, under which it is proposed to be sod: 6. Board shall be deemed to be an additional category of drug for the purpose of this Schedule. * This product has been authorised to be place of the market for use in this country. 16. (c) The manufacture shall be conducted under the 'active directions and personal supervisions of competent technical staff conisting of at least one person who is a whole-time employee and who has-- This page provides an overview of healthcare and pharmaceutical industry licensing in Michigan for individuals and businesses. (2) Trimming machine. The word "safe" shall not be used with respect to promotion unless properly qualified. The Ministry of Health and Family Affairs issued the Cosmetic Rules in December 2020, which states that a drug license is mandatory for importing cosmetics into India. (2) Mixer. Resorcin. 6.6.1 Storage and disposal (u) "half-finished product" means any material or mixture of materials that has to undergo further manufacture; 7.2.4 Microbiological monitory Name of drugs with quantity to be manufactured. (9) Miscellaneous. 2.2 Terminally sterilized products 24. 21. 66. 13. 10.4.5 Analytical records 3.5.2 Suppliers audits SECTION--6 (3) When a licence is cancelled or suspended, an entry to that effect shall be recorded on the licence. (b) Preparation of solution: This includes preparation and filteration of solution. Potassium Citrate. Licensing requirements for Michigan healthcare and pharmaceutical companies and individuals. (7) The licensee shall comply with the provisions of the Ordinance and the rules and with such further requirements, if any, as may be specified in any rule subsequently made-in this behalf or any other condition that may be imposed at the time of grant of a licence in the special circumstances of each case. (i) a degree in Pharmacy from a university in Pakistan or any other institution recognised by the Federal Government for the purpose of the Ordinance and has at least twelve months of practical experience in the manufacture of drugs; or FOR EXPERIMENTAL PURPOSES (h) Any other teats. 4.9.4 Reporting health problems (3) Weighing and measuring equipment. (j) Cost Accountant of the Ministry of Health; 16. Local exhaust system must be effective,. (ad) "new drug" means a drug that has not been commonly sold or distributed to the public in Pakistan and is introduced for the first time; 3.7.3 Written procedures Staff must not be allowed to go home wearing the same clothing they wore at work; emergency showers and eye washing facilities must be provided in the premises. Preparation of live organisms Serial Number, (g) Results of assay. SECTION-3 22. 4. (i) The licence will be in force for a period of five years from the date of issue unless earlier suspended or cancelled. Submit your FPGEC application in the Foreign Pharmacy section of NABP e-Profile. (E) The following equipment is required for filling of Hard Gelatin Capsules:- (a) rupees one thousand for the registration of new drug; Name and quantity of drug(s) to be manufactured for the said purposes:. Airlock system Results and remarks, Monitoring each cycle (iii) the dosage; pharmacy license requirements in pakistan pharmacy license requirements in pakistan Examination and course Description When submitting Continuing Education correspondence, it is necessary for you to send it via email to BPL-BoardSupport@michigan.gov.. 6 wherever necessary. Retailer's discount: The retailers discount shall be 15% of the maximum retail price. 4.8.3 Specific training The profit margin of retail pharmacies or medical stores ranges from 15 20 to 20% for each product. 6.2.6 Labelling 7. 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. Prescribers and dispenses shall not solicit such inducements. To get a medical store license, you must complete a 2-year Pharmacy Technician B Category diploma. Weight of each rabbit. Certificate regarding sale and G.M.P. 44. wherever necessary The premises and plan will be ready for inspectionon or are ready for inspection. 7.4.4 Process continuity {4) Heater and exhaust system, where applicable. 10.4.8 Standard operating procedures 10.1.4 Status identification 3.6.3 Written procedures (ii) the route of administration; 17. 2. (4) The Central Licensing Board may co-opt any other person who is expert in the pharmaceutical or medical profession for advice on any particular matter under consideration. GOOD PRACTICES IN MANUFACTURING PROCESSING Patent number, if any, with date and its date of expiry : (a) for adults. 5. Zinc Oxide. (x) "large-volume parenterals" means sterile solutions intended for parenteral application with a volume of more than 100ml in one container of the finished dosage form; 1. and Denmark. 3.1 General . 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