(g) any failure of one or more distributed batches of that drug to meet the required specifications; 3. how to apply dha exam for pharmacist. (4) If the application for renewal of registration is made after the expiry of the period of the validity of the certificate or registration, it shall be treated as a fresh application for the registration of drug. Control reference numbers in respect of the lot of glass containers used for filling. 6.6.4 Additional testing of reprocessed materials Name of Drug(s). (1) Storage equipment for ampoules and vials (au) "Schedule" means Schedule to these rules; 6. 3.6.5 Investigations FORM-5B 6. Name of the registered drug, with its registration number and date or initial ,registration and last renewal ' 5. 7. Composition of the drug stating quantity of each active and non-active ingredients per unit dose or percentage of total formulation: 53. Process to apply for a Drug sales License: 1) Fill a prescribed form-5 in Drug Rules. General 34. 17. S.R.O. 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". Bismuth Subnitrate. Finishing of sterile products Board shall be deemed to be an additional category of drug for the purpose of this Schedule. (a) The licensee shall comply with the requirements and the conditions in respect of goods practices in the manufacture and quality control of drug; as specified in Schedule B-II. Rs. 8. 4.5 Duties of Heads of Departments [See rule 21(3)] A. 52. 6.2.4 Damaged container (3-B) Any application under sub-rule (1) or sub-rule (3) shall be accompanied by the proper fee specified in Schedule F. 7.4.8 On-line packaging checks 8. (2) The Registration (2) The Registration Board may, before issuing a registration], cause the premises in which the manufacture is proposed to be conducted to be inspected by itself or by its sub-committee or by a panel of Inspectors or experts appointed by it for the purpose, which may examine all portions of the premises and the plant and appliances, inspect the process of manufacture intended to be employed and the means to be employed for standardising, if necessary, and testing the substances to be manufactured and enquire into the professional qualifications of the technical staff employed. Bio-availability, Bio-equivalence and Pharmacokinetics Analysis (For Dosage Form Introducing first time in Pakistan). 17. 08.80.040 . (a) on request, report in duplicate of all records respecting the information contemplated by paragraphs (d), (e), and (f) of (a) The generic name(s) of the active ingredient(s); You will need to complete an Applying for eligibility to complete an Overseas Pharmacists' Assessment Programme (OSPAP) form so that we can assess your eligibility to apply for an OSPAP course. (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-- The application fee is $147. If drains are absolutely necessary they must not contract directly with waterways or public sewers, (12) The licensee shall on being informed by the Central Licensing Board or a Provincial Quality Control Board that any part of any batch of a drug has been found not to conform with the requirements of the Ordinance or the rules and on being directed so to do, withdraw the remainder of the batch of such drug from sale and, so far as may in the particular circumstances of the case be practicable, recall all issues already made from that batch and dispose it of in such manner as may be directed by the said Board. (3) Sifter or sieve. (10) The Licensee shall, on demand, furnish to the Central Licensing Board or the Provincial Quality Control Board or to such authority as the Central Licensing Board may direct, from every batch of a drug, or from such batch or batches of drugs as it may from time to time specify, a sample for examination and, if required, furnish full Protocols of the tests which have been applied. Personnel Sodium Bromide. (14-A) The contributions made towards the Central 'Research Fund under sub-rule (14) shall be kept in such bank as the Federal Government may specify and shall be utilised in accordance with the Drugs (Research) Rules, 1978. 4.8 S.O.Ps for Testing 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'. (f) any bacteriological or any significant chemical or physical or other change or deterioration in any batch of that drug; [See rule 26(I)] 34. (i)All claims shall be made in accordance with these approved for registration of that drug. May include compounding Non-Resident 3.4.3 Self inspection team Pituitary (Posterior Lobe) Extract. Invoice/Challan number and date. Panamanian domestic regulations also require that the . Results and remarks, Granulating Section: (1) Disintegrator, where applicable. Methyl Salicylate. By way of repacking Rs. Provided that in the case of drugs specified in Schedule C, the Central Licensing Board may allow the applicant to make arrangements with some other institution approved by the Central Licensing Board for such tests to be regularly carried out on his behalf by that institution. Control reference numbers in respect of raw materials used in formulation. (c) Any other tests 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. (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. 19. 13. Profit and loss statement as per audited accounts for the last five years : 6.10 Waste materials 7. 2. (ab) "master formula" means a document or set of documents specifying the starting materials with their quantities and the packaging materials, together with a description of the procedure and precautions required to produce a specified quantity of a finished product as well as the processing instructions, including the in-process controls; (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; MANUFACTURE BY WAY OF FORMULATION Pennsylvania Licensure Requirements. Islamabad | Karachi | Lahore | Peshawar | Quetta; Phone: 0800-03727 (Mon to Fri 08:00AM to 04:00PM) Website: www.dra.gov.pk; Note 3: The Central Licensing Board may as its discretion direct the licensee to maintain records for such additional particulars as it may consider necessary in the circumstances of a particular case. Prescribers and dispenses shall not solicit such inducements. Name of the drug: The walls and floor shall be such as may permit their being sprayed and washed with an antiseptic solution. 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. (3) Dust proof storage Cabinets. 18. (4) Oven thermostatically controlled. 7.4.6 Label verification (vi) Environmental Controls 7. 5. ST-PHARMACY@PA.GOV. Mr./Messrs .. of is/are hereby licensed to manufacture the drug(s) specified below for experimental purposes at :. Duration of certificate of registration: A certificate of registration under this chapter, shall, unless earlier suspended or cancelled, be. 6.9.1 Testing prepared reference standard (Such observations should be utilized for appropriate labelled storage conditions or warning statements). 5,000 24. Sterility test as the last measures (c) Recommended storage conditions and expiration date to be assigned to the specific formulation and package.. This page provides an overview of healthcare and pharmaceutical industry licensing in Michigan for individuals and businesses. Sulphur Sublime. 1. For Foreign-trained Pharmacy Graduates / Pharmacists. 4.9.6 Appropriate clothing and covering 6.2.6 Labelling Preparation of live organisms A health-care professional licensed to engage in the practice of pharmacy with duties including dispensing prescription drugs, monitoring drug interactions . 4.9.5 Avoiding direct contact with materials 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. 3.7.3 Written procedures Quality control Phenothlazine (B. VET. APPLICATION DEADLINES AND EXAMINATION DATES. Calculated Paid investment Turnover [Omitted vide S.R.O. 15. 871(I)/78, dated 8th July, 1978.] 1.4 There shall be a written contract covering the manufacture and or analysis arranged, under contract and any technical arrangements made in connection with it. SECTION -- 9 DRUG REGISTRATION FEE (a) Generic/international non-proprietary name: 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. (2) They shall come into force at once. 7. Following statement, as per audited accounts/based on Income Tax Return for the last five years:- 13. 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. (ay) "starting material" means any substance used in the production of a pharmaceutical product but excluding packaging materials; 7. Date of commencement of manufacture and date of completion. 6. The text shall be fully legible. 2.3 The contract giver shall ensure that all processed products and materials delivered by the contract acceptor to comply with their specifications or that the product has been released by the authorised person(s). (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). Countersigned by .. prevent, the entry of air from outside. (w) "intermediate product" means partly processed material that must undergo further manufacturing steps before it becomes a bulk product; In order to gain the license to practice pharmacy, applicants will be required to complete two stages of examinations. 4.11 Labels (5) The Chairman and the Secretary of the Registration Board shall, after the Board has approved the registration of a drug, sign the certificate of registration. (8) In respect of new drug, records, including adequately organised and indexed files, shall be maintained containing full information regarding-- Calcium Carbonate. DRUG MANUFACTURING LICENCE FEE SECTION--6 Under the Pharmacy Act-1948, now all registered pharmacists in Maharashtra state pharmacy council are required to renewal of the pharmacist certificate created for themselves as per the rules made by the MSPC.. (r) "Form" means a form set forth in Schedule A; 1. Forms of licenses to sell drugs .- The licensing authority shall issue a license of a pharmacy in Form 9 and a license of a medical store in Form 10. 9. (4) A drug or any substance referred to in clause (ii) of Section 24, may be advertised through Press without reference to the Federal Government if it is merely intended to inform the public of the availability or the price of such drug or any substance referred to in clause (ii) of Section 24 subject to the condition that the Federal Government may prohibit such advertisement if, in its opinion, the public interest so requires. (8) The licensee shall allow any member of the Central Licensing Board or of a Provincial Quality Control Board or an Inspector to enter, with or without prior notice, any premises and to inspect the plant and the process of manufacture & the means employed in standardising and testing the drugs and to take samples for test and analysis. WV Board of Pharmacy 1207 Quarrier Street, 4th Floor Charleston, WV 25301 Phone: 304-558-0558 Fax: 304-558-0572 Email: Contact Form | boardofpharmacy@wv.gov 4.8.1 Written programme (4) Water still. (ii) unhygienic practices eating and smoking shall not take place in any production or quality control area; On Income Tax Return for the last five years: - 13 '' means to... Team Pituitary ( Posterior Lobe ) Extract for registration of that drug composition of the registered drug, with registration... Overview of healthcare and pharmaceutical industry licensing in Michigan for individuals pharmacy license requirements in pakistan businesses hereby licensed to manufacture drug. Appropriate labelled storage conditions or warning statements ) ( au ) `` Schedule '' means Schedule to these rules 6. The drug ( s ) accordance with these approved for registration of that.. 2 ) They shall come into force at once.. of is/are hereby licensed to the... 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