Yes, the physician must obtain from the Board of Pharmacy a license to dispense. An area of minimum of 200 square feet is required for the basic installations. (i) Equipment By way of formulation Rs. Provided that where a person possess or applies for a licence to manufacture by way of basic and he also intends to conduct semi-basic manufacture of drugs, he may conduct such manufacture under the same license, subject to the approval of, and under such conditions as, the Central Licensing Board may specify, and Airlock system [Omitted vide S.R.O. (F) The following equipment is required for ,the manufacture of Surgical Dressings other than Absorbent Cotton Wool Personnel (3-A) Application for renewal of registration of a drug shall be made in Form 5-B. Antigen. 21. As a first step, your business must obtain a resident or in-state pharmacy license from your state's licensing agency. 2,500 (b) PH wherever applicable, 6.3.3 Reference numbers 2.2 Terminally sterilized products (4) Folding and pressing machine for gauze. Degree or. 7.3.6 Product pipelines Address Medical Representatives.- (1) Medical representatives shall have an appropriate educational background. (i) the manufacturing premises shall be maintained properly and shall, as far as possible, be orderly , clean and free from accumulated waste and vermin; Methyl Salicylate. 9.2 Process validation (2) Analgesic Balms/Plasters. Schedule an inspection 10. Contract Giver 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 :-- The following equipment is required in each of the three sections :- Stability Summary : (Such observations should be utilized for appropriate labelled storage conditions or warning statements). _________________________ Fumigation Name of the drug: Documentation RESPONSIBLE PERSON REQUIREMENTS FOR LICENSURE Updated 12/5/2022 Pursuant to rules 4729:5-2-01 and 4729:6-2-01 of the Ohio Administrative Code, the Board . (2) In addition to approved package inserts and leaflets wherever available the preparation and distribution of booklets and other information material for patients and consumer shall also comply with the ethical criteria enunciated in this schedule. 9. (7) In case of an imported drug, the indenter or any other approved representative in Pakistan of the foreign firm shall ensure regular and adequate supply of tee drug in Pakistan. 62. MATERIALS Processing This licence permits the manufacture of Precautions during cooling General 28. 10. 17. (b) Proprietory name, if any: 7. (10) Filling and sealing unit 7.3.9 Repair or maintenance Number of containers filled. 15. 4.3 Specifications for Starting and Packaging Materials SCHEDULE B-I Maintenance of equipment . degree from a college accredited by the Accreditation Council for Pharmacy Education (ACPE). (t) "good manufacturing practices for pharmaceutical products" means part of quality assurance which:-- (3) When a licence is cancelled or suspended, an entry to that effect shall be recorded on the licence. [See rule 26(3A)] 6.3 Packaging materials 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. 19. (ii) Batch number(s) (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. Granulating Section: (1) Disintegrator, where applicable. (e) dosage form or regimen; (i) Name of the proprietor/directors/partner(s) (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; 60. Phenothlazine (B. VET. B.S. 7.3.7 Water pipes 34. Provided further that, if in the opinion of the Registration Board it is necessary so to do in the Public interest, it may provisionally register a [.] drug for period of two years. Verification can be emailed Licence to Manufacture Name and address of the manufacturer 17. 1. 5.2 Dedicated Facilities for Production 5. DOCUMENTATION (a) The generic name(s) of the active ingredient(s); 6.6.1 Storage and disposal 4.10 S.O.Ps Miscellaneous Aseptic Filling and sealing room: Certified that following drug(s) are hereby registered under the Drugs Ordinance/Act, 1976:- Pharm.D. 16. 7.1.8 In price controls (225 ILCS 85/9) To add the STUDENT designation to your Pharmacy Technician license, you must submit: Proof of your status as a Student in an approved College of Pharmacy OR 1. (ii) Details of the premises including layout plan of the factory. 4. III. (d). Potassium Citrate. 6. 25. Note:-Strike off which is not applicable (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. The application can be extensive and is usually accompanied by fees, a surety bond, proof of insurance, and copies of policies, procedures, or prescription labels. The more commonly issued license is the "practitioners of the healing . 1. 5,000 Any wording and illustration on the package and label shall conform to the principles of ethical criteria enunciated in this Schedule. The licence is subject to the conditions prescribed in rule 22 of the Drugs (Licensing, Registering and Advertising) Rules, 1976, and such other conditions as n3ay be subsequently prescribed or Specified by the Central Licensing Board in this behalf. 38. 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: Monitoring each cycle 3.7.5 Distribution records 26. General (b) The applicant shall provide adequate space, plant and equipment for the manufacturing operations, the minimum space, plant and equipment for various operations are specified in Schedule B-1. 29. D. Raw materials: use to be included in the labelling warnings and precautions in use: symptoms of overdosage should be given alongwith the treatment including antidotes where required. (iii) facilities for vaccination and inoculation against the enteric or any other epidemic group of diseases; and 1. Graduates Pharmacist Collaborative Practice Certification (3) Polishing pan, where applicable, (i) Cost per retail pack of each active and non-active. Asepsis of articles in clean areas 5. (f) one pharmaceutical chemist or expert in quality control, to be nominated by the Federal Government; (1) Mixing tanks where applicable: (3) Sifter or sieve. This room shall be air-conditioned. license in state where pharmacy is located and Ohio RPH license if shipping compounded medications. Value of raw materials used (Active & inactive) (in Rs.) Don't have an Account? APPLICATION FOR LlCENCE TO MANUFACTURE DRUG(S) FOR EXPERIMENTAL PURPOSES. 22. 12. 8. This sort of license may be found here. ---------------------- 42. APPLICATION FORM FOR REGISTRATION OF A DRUG FOR LOCAL MANUFACTURE (c) Recommended storage conditions and expiration date to be assigned to the specific formulation and package.. Number and size of containers filed and number rejected. GOVERNMENT OF PAKISTAN 6. Certificate regarding sale and G.M.P. (d) Floors: Floors should be impermeable to liquids, smooth and free from cracks. (iii) Details of the section-wise equipment and machinery for manufacture and quality control. (2) Ampoule washing and drying equipment. or at such other place(s) at the. 3. (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. Total. 9. (5) Dental preparations. FORM 5 General 2.6 Filters For the procedure to withdraw your application, contact the Pharmacy Unit at opunit1@nysed.gov or by calling 518-474-3817 ext. Submit your FPGEC application in the Foreign Pharmacy section of NABP e-Profile. The Tableting Section shall be free from dust and floating particles. SECTION--6 (b) rupees five hundred for the registration of any other drug; and Procedure (2) No person who is a member of the Appellate Board shall be nominated to the Central Licensing Board. Sodium Bromide. All arrangements for production and analysis must be in accordance with the registration and agreed by both parties. 3. (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: No. 5. The granulation, tableting and packing shall be done in this room. (v) licence to manufacture for experimental purposes. (C) The licensee shall comply with such further requirements, if any, as may be specified under any rule subsequently made. S.R.O. 8. Pituitary (Posterior Lobe) Extract. (3) Substantiated information on hazards associated with the drug shall be reported to the Registration Board as a priority. SCHEDULE D Committee on Safety of Medicines of U.K. or corresponding agencies of France, West Germany, Japan, Sweden. (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. Validation Stability studies : Precautions against contamination Ferric Ammonium Citrate. (iii) Details of the section-wise equipment and machinery for manufacture and quality control. (e) Type of container/package, with the nature of material, package testing (chemical, mechanical, environmental). Name of drugs with quantity to be manufactured. 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. (c) the generic name(s) of other ingredient(s) known to cause problem(s) Contract production and analysis 20. (2) Dosage form(s) of drugs. [See rule 21(3)] 12. 4.9.1 Health examination 19. Recording sterilization cycle (4) A fee of rupees one hundred shall be paid for a duplicate copy of the licence if the original is defaced, damaged or lost. 22. Pharmacies must also be registered with the GPhC (or be a pharmacy department based in a hospital or health centre) to operate in Great Britain and to use the title 'pharmacy'. (a) adequate space and equipment shall be provided; Ephedrine Sulphate. Conduct of Clinical Trials and Bio-equivalence/ Bioavailability 58. Checking integrity of filters ST-PHARMACY@PA.GOV. 1. Use the following forms and instructions to complete the application process: License Examination Instructions. (4) Water still or Deioniser. 2. 47. 5. (c) major precautions, contra-indications and warnings, if any; and There are, in addition, other categories such as drugs miscellaneous pharmaceuticals such as Ferries Ammonii Citras. Application fee for Advertisement. Provided that the conditions of location may be relaxed by the Board in suitable cases for grant or renewal or a licence subject to such conditions as it may deem fit, if the surroundings and the premises, in the opinion of the Board, are satisfactory for the intended manufacture. (i) licence to manufacture by way of basic manufacture. HTML PDF: 246-945-246: Wholesaler. 35. 3. 7.4.9 Product re-introduction on packaging line 3.4.6 Follow-up Action 1 2 3 (c) as soon as possible and in any event within fifteen working days of their receipt by him, reports in duplicate of all records respecting the information contemplated by paragraphs (g), (h) and (i) of sub-rule (8). For Foreign-trained Pharmacy Graduates / Pharmacists. 12. 4. Duration: 2 years, annual system, NTS based examination Eligibility: 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. (a) Description. 1. 3.5.2 Suppliers audits Name of the sample. Calamine. [See rule 30 (11)] (1) These rules may be called the Drugs (Licensing, Registering and Advertising) Rules, 1976. Activities in clean areas kept minimum 6. 6.6.2 Reprocessing (k) Price of the drug, ; and (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. 37. Drug Regulatory Authority of Pakistan. In package inserts or leaflets the manufacturers or distributors shall ensure that the information reflected is correct. (b) Identification. Licensing authority: For the purpose of Section 18 of the Ordinance the Secretary to the Government of Province in the Health Department shall be the licensing authority for that Province. Anyone who is not registered with the GPhC but practises as a pharmacist or pharmacy technician, or refers to themselves as such, is breaking the law and can be prosecuted. Validation 10. (9) Benches for filling and sealing. (ai) "processing instructions or procedures" means a defined in clause (ab) of this section; 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. 1. Simulation of aseptic operations validation (c) Filling and sealing: This includes filling and sealing of ampoules or filling and capping of vials. DRUG REGISTRATION FEE (3) Reminder advertisements shall include, amongst others, at least the international non-proprietary name or generic name, the name of each active ingredient and the price of drug and the name and address for the manufacturer or distributor for the purpose of receiving further information. 1.2 Surroundings Find funding 5. 4.4 Manufacturing, analytical and distribution records and reference samples shall be kept by, or be available to, the contract giver, and any records relevant to assessing the quality of a product in the event of complaints or a suspected defect shall be accessible and specified in the defect or recall procedures of the contract giver. (5) Pessary and tablet counter. Note: Records regarding various tests applied (including readings and calculations)should be maintained and necessary reference to these records should be entered in Serial No.7. 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