Protocols of tests applied (c) Recommended storage conditions and expiration date to be assigned to the specific formulation and package.. Finishing of sterile products (4) In the room provided for aseptic filling and sealing, necessary measures for maintaining sterility and to preventing contamination shall be adopted. HTML PDF: 246-945-233: Hospital pharmacy associated clinics. Requirements for a pharmacy permit vary by state, but many permit applications ask for: The type of pharmacy (Retail, Hospital, Sterile Compounding, Nuclear, etc.) 6. (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. 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! Conditions or registration of drug: (1) The relevant provisions of the Ordinance and the rules in respect of the registered drug, shall be complied with. 45.00 Initial Fee. Process to apply for a Drug sales License: 1) Fill a prescribed form-5 in Drug Rules. Guide to Continuing Pharmacy Education Requirements for Pharmacy Technicians. 3. The License can be renewed as it is valid for up to five years. We recommend that you send all supporting documentation to NABP at the time of submitting your application. Compound Effervescent Salts, [--] , Milk of Magnesia. 5. Conditions for Advertising: (1) The Federal Government may, after seeking advice of the Committee on Advertising, allow the advertisement of a drug, or any substance or a remedy as specified in Schedule D-1 or a treatment or offer of a treatment for any disease. SECTION -- 8 Calculated Paid investment Turnover 6.3.2 Printed materials 3.6 Complaints A minimum of 1 hour of CE earned in the area of pharmacy law. In order to apply for a license or submit a service request, you must first have a DELPROS user account. If it is not possible, the reasons therefor. Gripe Waters. Statement of the Central Research Fund. Aspirin and Paracetamol in tablets and liquid forms. 2. 10,000 C.). 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:- 3.2 Laboratories (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. Pharmacy (In-State Only) License. (1) Mixing and blending equipment. (f) Pyrogen test, wherever applicable. 6.3 Workshops (3) Name of the drug(s). (4) Antidandruff preparations. 7. Response. (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. Actual production and packing particulars. SECTION--4 Pharmacological group _________________________ Pharmacy licensing. 8. (vii) Packaging 3.7 Product recalls Drug Manufacturing License; Medical Devices Establishment Licenses; Alternative Medicines & Health Products Establishments; Application Process; Good Practices Compliances (GxP) . 19. 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. An area of minimum of 200, square feet required far the basic installation, Certified that following drug(s) are hereby registered under the Drugs Ordinance/Act, 1976:- Name of the Company .Type of ownership (Partnership, Proprietorship, Public limited, Private limited, etc.) Schedule B, in paragraph (2), in clause (k), for the semi colon and word"; and" a colon shall be substituted and thereafter the following proviso shall be inserted, namely: It is compulsory to pass the DHA exam in order to practice as a licensed medical professional in Dubai. 3. 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 :-- [See rule 31 (10)] General 7.1.8 In price controls 25. General (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. (Such observations should be utilized for appropriate labelled storage conditions or warning statements). 32. Sodium Sulphate. (d) Sterilisation. (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). 2. (2) The Registration Board may refer any case for detailed .examination to the committee of experts on the Drugs Evaluation constituted under Section 10 of the Act. 4. (13) Inspection table with draft and light background 08.80.040 . (am) "quality control" means the part of good manufacturing practices concerned with sampling, specifications, and testing as well as the organization, documentation, and release procedures which ensure that the necessary and relevant tests are actually carried out and that materials are not released for use, nor finished products released for sale or supply until their quality has been judged to be satisfactory and it is involved in all decisions concerning the quality of the product; and dispensing of drugs established under (b)(7) of this section must be consistent with the requirements of secs. Proposed route of administration: 2. (c) the statement of all the representations to be made for the promotion of the drug in respect of-- Temperature of each rabbit noted at suitable intervals, Kaolin. 5,000 10.4.1 General Quality control Note: Copies of balance sheets to be enclosed with the application for renewal only"; and (2) When lay language is used the information shall be consistent with the approved scientific data or other legally determined scientific basis for approval. 2.1 General SECTION -- 7 (d) one pharmacist, to be nominated by the Federal Government; Labelling : Specimen or draft with colour scheme, alongwith the undertaking to refrain from counterfeiting shall also be submitted. 10.1.4 Status identification Monitoring endotoxin 33. Frequency of use of filter (ii) Tableting Section; Short title and commencement: . (3) Scientific data in the public domain shall be made available, on request, to prescribers and any other person entitled to receive it as appropriate to their requirements. 35. 10. ETHICAL CRITERIA FOR MEDICINAL DRUG PROMOTION 1.Analytical report number (3) If a person possesses, or applies for, more than one type of licences to manufacture drugs in the same premises, he may establish one Quality Control Department for the purpose of both the licences. Duration of certificate of registration: A certificate of registration under this chapter, shall, unless earlier suspended or cancelled, be. Type of licence Fee Care against fibers Expenditure on advertisement: No person shall spend more than five per cent of his turnover on advertisement, sampling and other promotional activities in respect of drugs, (All weighings and measurements shall be checked initiated b the competent person in the section). (i) 10.3.3 Recording process operation 13. If you have an active intern registration in Kansas, you may only need to pay $100. 3.7.7 Evaluation (3) Polishing pan, where applicable, 7. [See rule 26(I)] 4.8 Packaging Materials 2.5 Tanks (a) Description. (ii) Reasons thereof. SCHEDULE G PROFORMA APPLICATION FORM FOR REGISTRATION OF A DRUG FOR LOCAL MANUFACTURE 3.5 Quality Audit Biological indicators Labeling of drugs manufactured for experimental purposes: (l) Any d-rug manufactured for experimental purposes shall be kept in containers bearing labels indicating the purpose for which it has been manufactured. 11. Complaints requiring surgical operation (e.g., appendicitis, stomach ulcers, prostatic disorders, hernias, sinusitis, mastodities. Resorcin. (d) Floors: Floors should be impermeable to liquids, smooth and free from cracks. 33. (6) The Registration Board shall, before registering a new drug for which the research work has been conducted in other countries and its efficacy, safety and quality has been established therein, require the investigation on such pharmaceutical, pharmacological and other aspects, to be conducted and clinical trials to be made as are necessary to establish its quality and, where applicable, the biological, availability, and its safety and efficacy to be established under the local conditions: (K) Requirements for the manufacture of Parenteral Preparations: The whole process of the manufacture of parenteral preparations may be divided into the following separate operations: (2) Medical representatives shall make available to prescribers and dispensers complete and unbiased information for each product discussed, such as an approved scientific data or other source of information with similar contents. Profit and loss statement as per audited accounts for the last five years : 6.2.9 Correct dispensing Value of raw materials used (Active & inactive) (in Rs.) (7) and Denmark. Sentonin. For this purpose, it is desirable that each tablet machine is connected either to an exhaust system or isolated into cubicles. (c) Any other tests 6. In package inserts or leaflets the manufacturers or distributors shall ensure that the information reflected is correct. 3, Batch Size, (2). 1.3 All arrangements for contract manufacture and analysis, including any proposed changes in technical or other arrangements, shall be in accordance with the registration of the drug concerned. 3, Batch number 10.1.8 Revision of specification Choose a License Type or Permit Pharmacist Licensure by Examination For U.S. and Puerto Rico Graduates Pharmacist Licensure by Endorsement for U.S. (10) Filling and sealing unit (e) any error in the labelling of that drug; (c) The manufacture shall be conducted under the active directions and personal supervision of competent technical staff consisting of. (B) For the renewal of Registration 7.2.1 Precautions against dust The manufacture and filling shall be carried out in art air-conditioned room under aseptic conditions. (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. 2. 6 wherever necessary. Pack size. 3. 3.3.7 Stability studies (v) licence to manufacture for experimental purposes. 4. (1) Class(es) of drugs. 7.4.1 Avoiding mix-ups 1. Contract acceptor 4.4 Specifications for Finished Products Name of Indenter/Manufacturer's agent/Importer (in case of imported drugs only). Gentian Violet. prevent, the entry of air from outside. Sterilized non-sterilizer products differentiation 10. 6.6.1 Storage and disposal 6.6.2 Reprocessing It is also certified that (a) the manufacturing plant in which the product is produced is subject in inspections at suitable intervals, and (b) the manufacturer conforms to requirements for good practices in the manufacture and quality control, in respect of products to be sold or distributed within the country of origin or to be exported. Batch number. 3. Male Female . 1993. 8. 3 Name under which drug is proposed to be sold 14. Sterility testing (4) Compressing machine. SECTION-I 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 2. 6.2.11 Labelling (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. (k) One physician, to be nominated by the Federal Government; 29. (5-A) Where the Registration Board registers a new drug, it may recommend to the Federal Government for fixation of maximum price of such drug. (3) Substantiated information on hazards associated with the drug shall be reported to the Registration Board as a priority. (d) The applicant shall establish an independent Quality Control Department and maintain separate staff, premises and adequate laboratory equipment for carrying out tests of strength, quality and purity of the substances being or to be used in the manufacture. Name of all ingredients, quantities required for the lot size, quantities actually used. Following statement, as per audited accounts/based on Income Tax Return for the last five years:- Symposia and other scientific meetings.- The intimation regarding scientific symposia, seminars, conferences and such meetings where sponsored by a pharmaceutical manufacturer or distributor shall be clearly communicated in advance. APPLICATION FORM FOR RENEWAL OF REGISTRATION OF ALL KINDS OF DRUGS 13. (iii) Written Procedures SECTION -- 5 3.4 Surfaces 1. 3.4 Self inspection 3. 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: 25,000 10.2 Specification for intermediate and bulk products wherever necessary (f) Any other tests. (c) rupees two hundred and fifty for the renewal of the registration of a new or any other drug: (p) "cross-contamination" means contamination of a staring material intermediate product, or finished product with another starting material or drug during production; APPLICATION FORM FOR REGISTRATION OF AN IMPORTED DRUG Renewal of a licence: On application being made for renewal, the Central Licensing Board may cause an inspection to be made, and if satisfied that the conditions of the licence and the rules are and will continue to be observed, shall issue a certificate of renewal or otherwise reject the application and inform the licencee accordingly. 5. (e) dosage form or regimen; The tanks or containers shall be made of either glass or such material which will not react with the liquid Pharmacy Internship Report - Updated 2/11/20 (178.62 KB) Pharmacist Online Application Supplement Packet_- Updated 2/11/20 (146.65 KB) Pharmacy Technician Additional Employment Form -Updated 2/11/20 (16.3 KB) Pharmacy Technician Change of Employment Notification Form - Revised 2/4/2022 (108.64 KB) Pic Change Request Form - Updated 2/20/20 (75. . Each state may have different individual . American Boards of Pharmacy SECTION -- 7 Suitability of process Sufficient time allowed to reach required temperature Form-7 License: This type of Drug sales license should be used for the sales of Medicines for Importers, Exporters, Indentors and Manufacturers. Free samples of prescription drugs for promotional purposes.- Free samples of drugs may be provided in modest quantities to prescribers, preferably on request. (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 4. 1362(I)/96-28.11.96). 34. Opinion and signature of the approved Analyst. 14. (i) adequate facilities for first aid; General Room: Sera. (i) Name of the proprietor/directors/partner(s) SCHEDULE B-I 6.7 Recalled and returned products (7) Liquid filling equipment. [See rule 16 (bb)-7] 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. Records of test to be carried out in case of tablets as under A written contract between the contract giver and the contract acceptor shall clearly establish the duties of each party had state the way in which the authorized person shall exercise his full responsibility in releasing each batch of product for sale or issuing the certificate of analysis and a copy of such a contract shall be supplied to the Central Licensing Board also. (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 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 :-- Signature of the Analyst. 13. (8) Hot Air Steriliser, 1.2 Surroundings 31. (5) If any defects or irregularities are recorded in the inspection book under sub-rule (4) the manufacturer shall take steps to remove such defects or irregularities. 8. If withdrawn from the market anywhere For this purpose, it is desirable that each tablet machine is connected either to an exhaust system isolated. 3.7.7 Evaluation ( 3 ) Name of the proprietor/directors/partner ( s ) be renewed as it is that... A drug sales License: 1 ) Class ( es ) of drugs and... Unless earlier suspended or cancelled, be first have a DELPROS user.! Manufacture for experimental purposes ) Floors: Floors should be impermeable to liquids, smooth and free from.! Lot size, pharmacy license requirements in pakistan required for the lot size, quantities actually used time of submitting application... K ) One physician, to be nominated by the Federal Government ; 29 2.5 Tanks ( a ).! Your application a DELPROS user account ( in case of imported drugs only ) 's (. 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