10.1.2 Recording actions Household remedies including-- 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. Particulars regarding the precautions taken during manufacture to ensure that aseptic conditions are maintained. (b) Identification. Conditions for the grant or renewal of licence to manufacture drugs by way of formulation: Before a licence to manufacture drugs by way of formulation is granted or renewed, the Central Licensing Board shall satisfy itself that the following conditions are being complied with by the applicant namely :-- (4) If the Registration Board, after such further enquiry, if any, as it may consider necessary, is satisfied of its safety, efficacy, quality and economical value or where the public interest so requires, it may register the drug and issue a certificate of registration in Form 6, subject to such specific conditions as it may specify.' Records in respect of each raw material shall be maintained indicating the quantity received, control reference numbers, the quantities issued from time to time, the names and batch Nos. 15,000 (ag) "packaging material" means any material, including printed material, employed in the packaging of a pharmaceutical product, excluding any outer packaging used for transportation or shipment and packaging materials are referred to as primary or secondary according to whether or not they are intended to be in direct contact with the product; 7. 6. 6.10.1 Storage Resorcin. 3.3 Protection Against Insects etc. PREMISES 2 Examinations. HTML PDF: 246-945-245: Health care entity license. 6.9.3 Working standards (a) for adults. Sentonin. 7.3.4 Cleaning containers 20. (3) Weighing and measuring equipment. 27. 6.5.2 Release 1. You'll also need to pass The North American Pharmacist Licensure Exam (NAPLEX) in order to practice in every state. 4.8.1 Written programme DRUG REGISTRATION FEE 12. Monitoring water supply of sources (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. 6.2.7 Identity of contents Using double filter layer 9. Register Your Self. Sanitation and hygiene (B) For the renewal of Registration Fumigation 11. 17. (9) Benches for filling and sealing. The Doctor of Pharmacy degree (often abbreviated Pharm.D. By way of basic Rs. (e) Testing, Have a desire to help 2. (c) the statement of all the representations to be made for the promotion of the drug in respect of-- (ii) medical inspection of workers at the time of employment and periodical check up thereafter at least once a year; 2. 7. 3.3.2 Sampling Name of drugs with quantity to be manufactured. 12. (c) two pharmacologists, to be nominated by the Federal Government. (2) Dosage form(s) of drugs. Details of Disposal 7. (3) A suitable power driven mixer. All Pharmacy Technicians licensed after January 1, 2008 must become CERTIFIED or STUDENT either when the license is issued or on or before the second license renewal. 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. [See rule 17(1)] (3) Sifter or sieve. (14) Leak tasting equipment. Japan, USA and European Company Member countries. (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. 6 wherever necessary. (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. A minimum of 17 hours of CE earned in any combination of the following pharmacy-related subject matter: Medication or drug distribution; Inventory control systems; Mathematics and calculations; Biology; Pharmaceutical sciences; Therapeutic issues; Pharmacy operations; Safety instructions should be strategically displayed in local language. 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. 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. Pharmacy Intern Permit. 1. 4.3 GMP awareness (2) An application under sub-rule (1) shall be countersigned by the head of the institution in which,. Programme participants are normally referred to as 'pharmacy interns'. 10. 4.1 General prevent, the entry of air from outside. 13. (2) Analgesic Balms/Plasters. 10.3 Batch processing records (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; 6.2 Changing Rooms (All weighings and measurements shall be checked and initialled by the competent person in the section). 6.8 Reagents and culture media Precautions during cooling 6.3 Packaging materials (c) Uniformity of weight. Dates of coating wherever applicable. Batch number. 1. Dosage from of the drug: Filling and Sealing Room: (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. (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. Pharmacy Services Last Updated on January 4, 2023 Following guidelines are intended to help the industry and other applicants to meet the regulatory requirements related to Clinical trials or bio equivalence centers/ studies and Advertisement of therapeutic goods. (v) "in-process control" means checks performed during production in order to monitor and if necessary to adjust the process to ensure that the product conforms to its specifications and control of the environment or equipment may also be regarded as a part of in-process control; By way of formulation Rs. 7.2.4 Microbiological monitory This sort of license may be found here. 16. 13. The granulation, tableting and packing shall be done in this room. (c) experiences, investigations, studies and tests involving the chemical or physical properties or any other properties of that drug; Prescription drugs should only be purchased from wholesale drug distributors licensed in the United States. Medical representative shall not offer inducements to prescribers and dispensers. Opinion and signature of the approved Analyst. Pharmacy Technician (Category-B) diploma holder is eligible to apply for license to open own medical store. Name of the sample. 5.1 General Facilities HTML PDF: 246-945-235: Nonresident pharmacy license. (iv) hygienic garments shall be worn by all staff in processing and packaging areas; Sodium Potassium Tartrate. 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. (5) A fee of rupees fifty shall be paid for a duplicate copy of the certificate of registration if the original is defaced, damaged or lost, and such copy of the certificate shall bear the words "Duplicate Copy". Pharm.D. 3.6.2 Person authorized Proposed C and F and maximum retail price (in case of imported drug) : (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); 3.7.8 Storage of recalled drugs 6.2.4 Damaged container (4) Folding and pressing machine for gauze. 4.7 Standard Operating Procedures (SOPs) and Records 4.3 The contract shall be describe clearly who is responsible for purchasing, testing and releasing materials and for undertaking production and quality controls, including in-process controls, and who has responsibility for sampling and analysis, and in the case of contract analysis, the contract shall state whether or not the contract acceptor shall take samples at the premises of the manufacturer. (d) Sterilisation. (f) one pharmaceutical chemist or expert in quality control, to be nominated by the Federal Government; *The whole course must be done in the campus of the University/Country . (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. (9) No act or proceeding of the Central Licensing Board shall be invalid merely on the ground of the existence of any vacancy in, or any defect in the constitution of the Board. 7.3.7 Water pipes 3.3.6 Production record/batch review Maintenance of clean area 53. APPLICATION FORM FOR RENEWAL OF A LICENCE TO MANUFACTURE DURGS BY WAY OF FORMULATION/BASIC MANUFACTURE/SEMI-BA SIC MANUFACTURE/REPACKING Normal temperature of each rabbit. (5) Pessary and tablet counter. Individuals who withdraw their licensure application may be entitled to a partial refund. Its steps are mentioned as follows Firstly download and fill the prescribed form-5 in drug rules ( click this link to download ). 201 - 208, P.L. license in state where pharmacy is located and Ohio RPH license if shipping compounded medications. [See rule 30 (11)] (3) The indications, contra-indication, side effects, the dosage and cautions, if any, as have been approved for the purpose of registration of a drug shall be clearly specified in the labelling and promotion. 7.1.7 Unauthorized entry prohibited [Omitted vide S.R.O. Registration Board 3.3.7 Stability studies (f) Any other tests. 3 Name under which drug is proposed to be sold 3.4.6 Follow-up Action (16) Storage equipment including cold storage and refrigerators, if necessary Sodium Sulphate. Develop a plan 4. Provided further that duration of a licence issued under rule 21 shall be two years unless earlier suspended or cancelled. 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. 6.5.1 Quarantine (11) If the Central Licensing Board or a Provincial Quality Control Board so directs, the licensee shall not sell or offer for sale any batch of a drug in respect of which a sample is, or protocols are, furnished under clause (10) until a certificate authorising the sale of the batch of such drug has been issued to him by or on behalf of the Central Licensing Board or the Provincial Quality Control Board, as the case may be. 9. 9. (b) the content of active ingredient(s) per dosage form or regimen; In case medicated dressings are to be manufactured, room with an area of minimum of 300 square feet shall be provided. (a) Clarity, This registration shall be valid for a period of five years unless earlier suspended or cancelled. SCHEDULE G 6 wherever necessary. (1-C) The approval of the advertisement, granted under sub-rule (1), shall be valid for a period of two years only. 7.3.9 Repair or maintenance 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. (6) If after the expiry of three months but within six months of the rejection of an application under sub-rule (4), the applicant informs the Central Licensing Board that the requirements of the rules have been fulfilled, the Board may if after causing a further inspection to be made, is satisfied that the conditions for the grant of a licence have been complied with, issue a licence and no further fee shall be required to be deposited for such an application. 4. Stability studies : 10.1.6 Reference standards identification Cetrimide Powder. Venereal diseases. Proposed dosage: 3. 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. Provided that deviations from any such information may be made only after obtaining prior approval of the Registration Board. 4. Protocols of tests applied. 8. Quality control. 2.7 Cleaning Equipment Provided that the Federal Government may, if in its opinion the public interest so required, withdraw the approval granted to any advertisement or modify or alter any condition subject to which the advertisement was approved. 4.6 Rejected Materials of the products for the manufacture of which the quantities have been issued and the particulars relating to the proper disposal of the stocks. (a) Generic/international non-proprietary name: I/We . of hereby apply for the renewal of a licence to manufacture by way of on premises situated at An area of minimum of 200 square feet is required for the basic installations. 1. 2. Benzoic Acid. (2) Capsule filling units. 11. (2) Where inspection under sub-rule (1) is carried out by a sub-commmittee or panel of experts of Inspectors appointed under the said sub-rule it shall forward to the Central Licensing Board a detailed report of the result of the inspection. About Us | Contact Us Search You & Your Family Community & Environment Licenses, Permits, & Certificates Data & Statistical Reports Emergencies For Public Health & Health Care Providers In this section Pharmacies Location and surrounding: The premises should be away from drinking water sources and an area liable to flooding. FORM 5 (1) Strict sanitation shall be maintained throughout the entire plant in order to prevent contamination and to keep out pyrogens, Masks end overalls shall be worn wherever necessary. By way of formulation Rs. and Denmark. [See rule 26(I)] 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. Serial Number. 14. There are two dispensing licenses offered by the Board of Pharmacy as outlined in guidance document 110-29. Place . Air supply system Note//: This Schedule gives equipment and space required for certain categories of drugs only. Drug Regulatory Authority of Pakistan. (ii) Any other relevant information that may be required by the Board for consideration of this application. Harrisburg, PA 17105-2649. 3.1 General (8) Autoclave. (5) Various liquid measures and weighing scale. Pharmacy Licensing | Washington State Department of Health Thank you for your patience as we continue to update our new website. Alniminium Hydroxide Gel Dried. Main Pharmacological group to which the drug belongs: Date of Registration Secretary Registration Board (Seal) Chairman. 3. Results and remarks, Substances Parenteral preparation in general: 3.2 Services Board shall be deemed to be an additional category of drug for the purpose of this Schedule. Potassium Chloride. 6, Date of injection, Licensing Requirements. 4.8.3 Specific training FORM 4 Personnel training Find funding 5. (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. Pharmacist Exam and License. 7.3.2 In-process controls General Certificate regarding sale and G.M.P. (i) The licence will be in force for a period of five years from the date of issue unless earlier suspended or cancelled. (k) Price of the drug, ; and (l) "clean area" means an area with defined environmental control of particulate and microbial contamination, constructed and used in such a way as to reduce and or eliminate introduction, generation and retention of contaminants within the area; Year The room shall be further dehumidified if preparations containing antibiotics are manufactured. 3.7.4 Recall with promptness 29. Special provisions regarding grant of a licence: (1) Where a manufacturer intends to manufacture a drug a part of the process of which is of specialised nature and would be uneconomical for him to conduct it, the Central Licensing Board may permit such process to be undertaken at another licensed premises specialised for this purpose, subject to such conditions, if any, as may be specified in this behalf. Bismuth Carbonate. (3) An application under sub-rule (1) shall be accompanied by fee or-- (2) Post-marketing scientific studies and surveillance shall not be misused as a disguised form of promotion. 5 whenever necessary. PART-II (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; 10,000By way of semi-basic Rs. 4.8.2 Training appropriate to duties Though licensing applications and processes differ from state to state, everyone will need the following: Proof of graduation from an accredited institution; 6.3.3 Reference numbers Provided that member nominated by a Provincial Government may follow the procedure as laid down for a Provincial Inspector. 6.9.2 Use This exam is to assess the student knowledge, ability to interpret and apply all legislation that impacts on current pharmacy practice in Ontario. 4.4 Prohibition of unauthorized person Washing of clothing GOOD MANUFACTURING PRACTICES (GMPs) FOR LICENCE TO 2.2 Terminally sterilized products PROFORMA Date of release finished packings for distribution or sale. Register Lost your Password? (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; (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. A total area of not less than 900 square feet for the three Sections is required for basic installations. 62. 40. Name and address of the agent or indentor in case of imported drug - Click GO on the Apply/Manage a License and Service Requests tile. (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. WHICH IS PROHIBITED 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. (z) "manufacturer" means a company that carries out at least one step of manufacture; Protocols of tests applied Caffein and its Salts. Retailer's discount: The retailers discount shall be 15% of the maximum retail price. 3.4 Facilities 23. 10. STATEMENT SHOWING QUARTERLY PRODUCTION TO BE SUBMITTED IN DUPLICATE having been made, approve of the manufacture of such categories of drugs. Potassium Iodine. FORM 7 5.2 Dedicated Facilities for Production Response. Contract Giver Results of assay. 10. (7) Steam steriliser or dry heat steriliser. 10.4.2 Pre-packaging line checks (iv) Names and qualifications of the Production Incharge and Quality Control Incharge for supervision of manufacturing processes and Quality Control Departments, and other technical staff working in these departments Control reference numbers in respect of raw materials used. (10) The chairman and the Secretary of the Central Licensing Board shall, after the Board has approved the issuance of a licence sign the licence. Note I: The foregoing provisions represent the minimum requirements to be complied with by the licensee. (i) ensure that products are consistently produced and controlled to the quality standards appropriate to their intended use are as required by the marketing authorization or product specification; and 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. Registration shall be done in This room guidance document 110-29 application FORM for of... 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