Insulin. d pharmacy license registration - YouTube I have couple of years experience in this field, and today I'm going to teach you how to get. 6.6.1 Storage and disposal C. For other drugs: Analgesics: 6.1.2 Appropriate storage 27. 30 Hours of Continuing Education. An area of minimum of 200, square feet required far the basic installation, (2) Where a person possesses or applies for a licence to manufacture by way of formulation and he also intends to conduct repacking of drugs, he may conduct such repacking under the same licence subject to the approval of, and under such conditions as, the Central Licensing Board may specify. 2. (3-A) Application for renewal of registration of a drug shall be made in Form 5-B. (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 13. Practiced pharmaceutical profession for a period not less than two years (for foreigners) Fluent Arabic and foreign language. Name and address of the manufacturer: (ii) Reasons thereof. . (3) Sealing equipment, Pharmacists who have completed all of the elements listed above can then apply for a license for the 1,000 hour clinical training programme. 14. in case of proprietorship the names) of proprietors and their address (es), in the case of firm the name and names and addresses of its partners and in the case of company the name and address of the company and its directors). This licence shall, in addition to the conditions specified in the rules made under the Drugs Ordinance/Act, 1976, be subject to the following conditions namely:- Process to apply for a Drug sales License: 1) Fill a prescribed form-5 in Drug Rules. Validation FORM-5B 7.4.3 Labeling packaging line Glycerin. (d) Extreme Temperature Fluctuations Study for all liquid and semi-solid preparations. 7.1.8 In price controls Borax. (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; Antigen. (13) Inspection table with draft and light background (a) Description. Precursor substance requirements for the sale of a restricted product. The training shall include instructions regarding appropriate ethical conduct taking into consideration the W.H.O. Pharmacy (In-State Only) License. 34. 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. Methyl Salicylate. (vii) Packaging 2.4 Piping C.). State Board of Pharmacy. 50.00 stamp papers as prescribed ( Click to Download- Affidavit) (1) Hot air oven electrically heated with thermostatic control. ---------------- 5 whenever necessary. Graduates Pharmacist Collaborative Practice Certification (A) For the grant of Registration Rs. 37. 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. (11) Bacteriological filters such as Seitz filter, candles or sintered glass filters, (3) Taking into account the media employed, advertisements to the general public may amongst others, contain, he following information:- 4.9.3 Illness Name of the sample. The contract (3) Cutting equipment. Captcha: 9 + 4 = Sign In. (5) A separate room shall be provided .for sterilisation, testing (for leaks and floating particles) and dryin Records of tests employed :-- Soft yellow Paraffin. (Seal) Chairman, Central Licensing Board. (iv) adequate precautions for safe-guarding the health of the workers, including measures to avoid industrial accidents or diseases. Sera. Sodium Thiosulphate. 3.7.3 Written procedures Each state may have different individual . (i)one copy of each issue of such journal or publication is sent to the Drug Administration of the Health Division; and (d) any directions for. 7.4.9 Product re-introduction on packaging line Apply for insurance 11. (5) Various liquid measures and weighing scale. Develop a plan 4. 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: 20. Use of protective garments (6) Finished products shall be stored in a suitable separate place. Name of drug, under which it is proposed to be sod: 3.2 Services (1) Rolling machine. ST-PHARMACY@PA.GOV. Graduates Pharmacist Licensure by Examination for Non-U.S. (k) One physician, to be nominated by the Federal Government; (iii) Surfaces CHAPTER I - PRELIMINARY 5.2 Hygiene Alniminium Hydroxide Gel Dried. 4.12 Batch processing records 3.5 Quality Audit (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. Signature of the expert staff responsible for manufacture. 4. 4. Pharmacological group _________________________ (b) To check the presence of foreign particles. Finishing of sterile products . 2. 4.9.7 Foods and drinks prohibited 6.2.9 Correct dispensing 7. criteria. Outside contractor Name of the drug: 3.7.7 Evaluation (g) "batch numbering system" means a standard operating procedure describing the details of the batch numbering; Caffein and its Salts. Explanation: The expenditure on pay and allowances of the field force connected with the promotional activities shall not be included in expenditure for the purpose of this rule. Name of the material (f) Pyrogen test, wherever applicable. 9.2 Process validation 3. 22. II. (2) Trimming machine. (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; Bioburden to be minimal 11. New processes to be validated Provided that such variation shall be recorded in writing with reasons therefor and also communicated in writing to the manufacturer for his record, 5. 1. (1) Mixing and pouring equipment. 18. Temperature of each rabbit noted at suitable intervals, (i) Class(es) of drugs. (H) The following equipment is required for the manufacture of Pessaries and Suppositories :- 13. Opinion and signature of the approved Analyst. Sterilized non-sterilizer products differentiation 6.2.4 Damaged container Advertisements shall also indicate, where applicable, appropriate limitations to the use of the drug. 10. Number of mice used and weight of each mouse, Strength and volume of the drug injected, 9. Quality control. Personnel (3) Where inspection under sub-rule (2) is carried out by a Sub-Committee or panel of experts or Inspectors appointed under the said sub-rule, it shall forward to the Registration Board a detailed report of ;he result of the inspection. Value of raw materials used (Active & inactive) (in Rs.) 10.1.8 Revision of specification Guide to Continuing Pharmacy Education Requirements for Pharmacy Technicians. (1) Storage equipment for ampoules and vials 3.1 General 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. In case medicated dressings are to be manufactured, room with an area of minimum of 300 square feet shall be provided. 12. Details of Disposal 5. 5. Application fee for Advertisement. 14. (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-- (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: Complaints requiring surgical operation (e.g., appendicitis, stomach ulcers, prostatic disorders, hernias, sinusitis, mastodities. Secretary, Central Licensing Board. Post-marketing scientific studies, surveilance and disseminaion of information.- (1) The Registration Board shall be made aware of any post-marketing clinical trials for drugs that are conducted and the results thereafter as soon as possible. 9. (8) Advertisement of a drug or any substance referred to in clause (ii) of Section 24 shall include such information or any risks and other precautions as may be necessary for the protection of public health, and in the case of drug also its maximum retail price fixed under Section 12. 8. If package inserts or leaflets are used for promotional purposes, they shall comply with the ethical criteria enunciated in this Schedule. Potassium Acetate. Prescription drugs should only be purchased from wholesale drug distributors licensed in the United States. (v) Drains (5) The Registration Board may, while registering a drug under sub-rule (4), approve the details as supplied by the applicant or approve them with amendments as it may deem fit in respect of the following particulars, namely :-- GOOD PRACTICES IN MANUFACTURING PROCESSING ------------------------ The room shall be further dehumidified if preparations containing antibiotics are manufactured. 3. [See rule 26(3A)] Date of filling. 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. (16) Storage equipment including cold storage and refrigerators, if necessary 7.3.8 Equipment calibration (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. 4. (Such observations should be utilized for appropriate labelled storage conditions or warning statements). 6. In case of pessaries manufactured by granulation compression, if the licence does not have a tablet section, a separate area of minimum of 300 squared feet and the following equipment is necessary :-- By way of formulation Rs. 4. SCHEDULE B I-A. 29. Programme participants are normally referred to as 'pharmacy interns'. 10. _________________________ S.R.O. [See rule 16 (6) (b)] 3.7.9 All concerned to be informed (12} Filling and. Powers of Registration Board: The members of the Registration Board shall exercise all the powers of Inspector without restriction as the area, and shall have the powers of a Provincial Inspector in relation to Section 30. For Foreign-trained Pharmacy Graduates / Pharmacists. 4.7 Standard Operating Procedures (SOPs) and Records Year Investment Turn-over 19. Personnel Address. 5. Normal temperature of each rabbit. 32. 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. [See rule 31 (10)] and dispensing of drugs established under (b)(7) of this section must be consistent with the requirements of secs. PART-II 7.1 Processing operations I/We of .. hereby apply for a licence to manufacture drug(s) specified below for experimental purposes at .. and I/We undertake to comply with the conditions applicable to the licence under rule 22 of the Drugs (Licensing, Registering and Advertising) Rules, 1976. Proviso: Added vide S.R.O. Sterilization by ethylene oxide Ephedrine Hadrochloride. (ao) "reconciliation" means a comparison, making due allowance for normal variation between the amount of product or materials theoretically produced or used and the amount actually produced or used; (7) The Central Licensing Board may authorise the Chairman to any of its members to perform any specific function of the Board for a specified period. 57. 6.2.10 Checking (2) Mixer. Central Licensing Board may from time to time permit. FORM 2A (m) "compounding" means scientific combination of two or more ingredients with a view to make a finished drug; (ii) unhygienic practices eating and smoking shall not take place in any production or quality control area; I enclose :- 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. (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. APPLICATION FORM FOR RENEWAL OF A LICENCE TO MANUFACTURE DURGS BY WAY OF FORMULATION/BASIC MANUFACTURE/SEMI-BA SIC MANUFACTURE/REPACKING license in state where pharmacy is located and Ohio RPH license if shipping compounded medications. 7. Sodium Iodide. Potassium Bicarb. Monitoring each cycle Chloral Hydrate. 3.4.3 Self inspection team (b) The applicant shall provide adequate space, plant and equipment for the manufacturing operations; While introducing the drug to the physician for the first time in shall contain full product information, on the basis of the approved scientific data sheet or similar document and shall contain, among others, the following information:- (c) The licensee shall either in his own laboratory or, where so authorised under the proviso to clause (e) of rule 16, in any other laboratory approved by the Central Licensing Board, test each batch of the raw materials used by him for the manufacture of drugs and also each batch of the final drug, shall maintain records showing the particulars in respect of such tests as specified in Schedule B-III 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. (3) Employers shall be responsible for the statements and activities of their medical, representatives. DOCUMENTATION We recommend that you send all supporting documentation to NABP at the time of submitting your application. 4. license by examination or by license transfer the applicants who are qualified to engage in the practice of . 3.3 Control procedures (b) the content of active ingredient(s) per dosage form or regimen; The room shall be air-conditioned and also dehumidified wherever necessary. Ephedrine Sulphate. 4.2 Written duties Protocols of tests applied [See rule (5(I)] This licence shall unless previously suspended or cancelled be in force for a period of two years from the date specified below:- 1. Powers of the Central Licensing Board: (1) The members of the Central Licensing Board shall exercise all the powers of an Inspector without restriction as to area, and shall have the powers of a Provincial Inspector in relation to Section 30. 18. 4.8.2 Training appropriate to duties (3) An application under sub-rule (1) shall be accompanied by fee or-- in the country of origin (in English and in Form 5 (c) : 16. 7.1.1 General 5.2 Dedicated Facilities for Production 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: 8. Name of the sample. 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. 2.2 The contract giver shall provide the contract acceptor with all the information necessary to carry out the contracted operations correctly in accordance with the registration and any other legal requirements and the contract giver shall ensure that the contract acceptor is fully aware of any problem associated with the product, work, or tests that might pose a hazard to premises, equipment , personnel, other materials or other products. Its steps are mentioned as follows Firstly download and fill the prescribed form-5 in drug rules ( click this link to download ). (at) "returned product" means finished product sent back to the manufacturer or distributor; REQUIREMENTS OF PLANT AND EQUIPMENT Labelling : Specimen or draft with colour scheme, alongwith the undertaking to refrain from counterfeiting shall also be submitted. SECTION -- 9 How to get a pharmacy license in Pakistan? 2.3 Construction Pharmacists measure and sell prescription drugs. 4.3 Bays 145 (I)/76 dated 12th February 1976:- In exercise of the powers conferred by Section 41 of the Drugs Ordinance, 1976 (IV of 1976), the Federal Government is pleased to make the following rules, namely :-- (2) The Central Licensing Board shall, before cancelling or suspending a licence under sub-rule (1), provide an opportunity of being heard to the licensee. (8) Where it is necessary in the public interest so to do, the Registration Board may register a drug on its own motion without having received any application for registration. (10) If a drug or any of its ingredients, which is imported or manufactured by a company in Pakistan is also approved for registration and free sale by its subsidiary, sister concern, associate or parent company in the country where it was originally developed or in any of the countries namely, USA, European Union Countries, Canada, Japan, Australia, and-- General Room: (3) Advertisements under sub-rule (2) shall be subjected to the following conditions, namely :-- (v) licence to manufacture for experimental purposes. (2) In the exercise of their powers the members of the Central Licensing Board shall follow the procedure prescribed for the Federal Inspector - 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. Prescribers and dispenses shall not solicit such inducements. (aj) "production" means all operations involved in the preparation of a pharmaceutical product, from receipt of materials, through processing and packaging, to its completion as the finished product; Handling procedures Name and address of the manufacturer: 2. 4. SECTION--4 Signed (ii) Tableting Section; Personnel training 12. APPLICATION FORM FOR REGISTRATION OF AN IMPORTED DRUG (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; Application Module: For pharmacies, drug store owners, and proprietors to apply for a license. (3) If the Central Licensing Board, after' such further enquiry, if any, as it may consider necessary, is satisfied that the requirements of the rules have been complied with, it may issue a licence in Form 2. Bacteriophages. (4) Water still. 201 - 208, P.L. PART-I 8. (a) "active pharmaceutical ingredient" means a substance or compound that is intended to be used in the manufacture of a pharmaceutical product as a pharmacologically active compound (ingredient); 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. (2) Power Mixer or granulation mixer with stainless steel cabinet Statement of the Central Research Fund. 6.11 Miscellaneous SECTION -- 5 3.7 Product recalls 6. (4) Oven thermostatically controlled. (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; General Gentian Violet. Protocols of tests applied. (i) licence to manufacture by way of basic manufacture. 3. 17, Actual production and packing particulars indicating the size and quantity of finished packings, (J) The following equipment is required for the repacking installation of drugs and Pharmaceutical Chemicals Phone - (717) 783-7156. (1-A) An application for advertisement of any drug, substance, remedy, treatment or offer of treatment for any disease shall be made it Form-8, addressed to the Secretary of the Commissioner on Advertising and there shall be made a separate application for each advertisement. (13-A) The licensee or his authorised agent shall issue a warranty in Form 2-A For any drug sold by him for the purpose of re-sale or distribution. 6 wherever necessary. 15, Reference to Analytical Report numbers stating whether of standard quality or otherwise. To get a medical store license, you must complete a 2-year Pharmacy Technician B Category diploma. Monitoring water supply of sources (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. 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. Opinion and signature of the approved Analyst. (a) Generic/international non-proprietary name: 7.4.5 Printing operation checks (aq) "repacking" means all operations involved in the transfer of a drug from a larger container or packing into smaller containers or packings including filling, packing and labeling with a view to make it ready for retail sale or wholesale, but does not includes any compounding, or processing with a view to formulate it in any dosage form; [See rule 21(I)] Sterilization by moist heat By way of repacking Rs. Name of all ingredients, quantities required for the batch size, quantities actually used. 66. (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. 10,000 (e) Signs: Signs indicating smoking restrictions, location of emergency kits, fire-fighting equipment, telephone end escape routes must be prominently displayed. (10) Rejection of an application for the registration of a drug shall not debar an applicant from submitting a fresh application under rule 26. HTML PDF: . Provided that an application for the renewal of registration shall not be entertained unless it has been made within sixty days after the expiry of the registration and when an application has been made as aforesaid the registration shall subject to the orders passed on the application for the renewal continue in force for the next period of five years : (9) Benches for filling and sealing. The fees for submitting your application include an application fee ($100) and an evaluation fee ($450). Please contact the Board at pharmacy@ks.gov for more information. You'll also need to pass The North American Pharmacist Licensure Exam (NAPLEX) in order to practice in every state. (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. 2.2 Terminally sterilized products SCHEDULE B-I (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 item. 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. (a) if that drug at any time, for safety reasons is withdrawn or banned or certain restrictions are imposed in any of the said countries, then it shall be the responsibility of the manufacturer in Pakistan or as the case may be, the indentor, to immediately withdraw the drug from the market in Pakistan or, as the case may be to impose similar restriction and to inform the registration Board within fourteen days of such an information having come to his knowledge and having taken the necessary action. Employers shall be responsible for the sale of a restricted Product license transfer the applicants are... 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