3.1 General 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. ---------------------- (j) Cost Accountant of the Ministry of Health; 7. Duration of certificate of registration: A certificate of registration under this chapter, shall, unless earlier suspended or cancelled, be. 1993. 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. (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. 6. 3 Name under which drug is proposed to be sold 536(1)/93 dated 23rd June 1993. 6.2.1 Purchase 7. Note: Particulars regarding various tests applied shall be maintained and necessary reference to these records shall be entered serial No. The premises and plan will be ready for inspectionon or are ready for inspection. 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. ENCLOSURES OF THE APPLICATION FOR REGISTRATION OF A DRUG (7) Advertisement material shall be presented with courtesy and good taste and words and phrases implying urgency, uniqueness or such expressions which are absolute in character, such as "the most potent", "the most rapid", "the most efficacious", or which make exaggerated claims or to general claims, such as "effective in all cases" or "effective against all complaints" or superlatives shall be avoided. 47. Yes, the physician must obtain from the Board of Pharmacy a license to dispense. 6.4 Intermediate and bulk products Simulation of aseptic operations validation 10. 17. 3.5.1 Audit by independent specialist 10. 2. (3) Substantiated information on hazards associated with the drug shall be reported to the Registration Board as a priority. Phone - (717) 783-7156. 5 whenever necessary. (5) Mixing and storage tanks of stainless steel or of other suitable material. Sodium Iodide. 50.00 stamp papers as prescribed ( Click to Download- Affidavit) SECTION--4 Description of the method of manufacture and quality control with details of the equipment. 33. Application for licence to manufacture drugs and fee therefor: (1) An application for the grant or renewal of a licence referred to in clauses (i) to (iv) of rule 3 shall be made in Form 1 or l-A to the Central Licensing Board addressed to its Secretary. Select correct technology 9. (f) Any other tests. (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. Sanitation Secretary, Central Licensing Board. Sulphur Precipitated. 18. sealing unit, (12) The manufacturer or, as the case may be, the indentor shall supply the information in relation to safety, efficacy, production, quality, or availability of the drugs as and when required by the Registration Board with a view to ensure safety, efficacy or quality of the drug. (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; 15, Reference to Analytical Report numbers stating whether of standard quality or otherwise. (a) The generic name(s) of the active ingredient(s); The Registration Board after getting the said intimation shall take similar action for the same drug available from other sources within the shortest possible time; (d) special groups. Name of drugs with quantity to be manufactured. 7,500 10. (5) Various liquid measures and weighing scale. 21. (6) Hot air drying ovens. or an officer of the Provincial Health Department not below the status of Additional Secretary, to be nominated by the Secretary, Health Department of that Province. Documentation 28. Universal Licensing Requirements. Super Easy Way to Start Pharmacy Business in Pakistan! 4. 7.4.7 Resistant printing on labels (4) Folding and pressing machine for gauze. (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; (iii) Name of the approved expert staff. (1) Sifter. (g) any failure of one or more distributed batches of that drug to meet the required specifications; (i) Granulating Section; Type of licence Fee SANITATION AND HYGIENE 61. 1.1 Location 20. Kaolin. 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. Pharmacist by Exam (Form LA-01E) Order a Fingerprint Card. 13. Following statement, as per audited accounts/based on Income Tax Return for the last five years:- Composition of the drug stating quantity of each active and non-active ingredients per unit dose or percentage of total formulation: 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. Weight of each rabbit. Cough Preparations. (ii) Tableting Section; (1) Rolling machine. (3) Weighing and measuring equipment. (2) If a person is conducting a part of the process of the manufacture on behalf of another manufacturer in accordance with the permission granted under sub-rule (1), and he is not responsible for the quality of the final product, the Central Licensing Board may not require him to establish an independent quality control laboratory for such products. Drug Regulatory Authority of Pakistan. 2. (al) "quality assurance" means the totality of the arrangements made with the object of ensuring that pharmaceutical products are of the quality required for their intended use and so incorporates good manufacturing practices, Quality Control and other factors including product design and development and good laboratory practices; (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; 14. 7. WHICH IS PROHIBITED Pituitary (Posterior Lobe) Extract. (16) Storage equipment including cold storage and refrigerators, if necessary 8. APPLICATION FORM FOR RENEWAL OF A LICENCE TO MANUFACTURE DURGS BY WAY OF FORMULATION/BASIC MANUFACTURE/SEMI-BA SIC MANUFACTURE/REPACKING Bio-availability, Bio-equivalence and Pharmacokinetics Analysis (For Dosage Form Introducing first time in Pakistan). (d) Omitted by S.R.O. 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. Pharmacy Intern Permit. (7) Liquid filling equipment. (e) any error in the labelling of that drug; 20A. 16. (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". 10.4.10 Equipment utilization record Warranty under Section 23(I)(i) of the Drugs Act, 1976 Ephedrine Sulphate. 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. 3.3.2 Sampling The walls and floor shall be such as may permit their being sprayed and washed with an antiseptic solution. Sterilization If the license you are reciprocating was obtained on or after June 22, 1976, and before May 12, 1986, minimum passing general average score of 70; or If the license you are reciprocating was obtained on or after May 12, 1986, minimum passing converted score of 75. c. Multistate Pharmacy Jurisprudence Exam (MPJE) - Pass with a minimum score of 75. Biological indicators 56. Pack size (s) and proposed maximum retail price with the following details:- PH of the solution wherever applicable. The fees for submitting your application include an application fee ($100) and an evaluation fee ($450). Find funding 5. Licenses State Board of Pharmacy Permit Drug Enforcement Administration (DEA) Number National Provider Identifier (NPI) Number Checking integrity of filters 4.9.3 Illness Duration: 2 years, annual system, NTS based examination Eligibility: Date of release finished packings for distribution or sale. By way of repacking Rs. Pharmacists who have completed all of the elements listed above can then apply for a license for the 1,000 hour clinical training programme. 58. (3) Antiseptics and disinfectants for household use, excluding those containing hormone and antiniotics. 6 wherever necessary. Date of commencement of manufacture and date when manufecture was completed, 15,000 Ancillary Areas 15,000 This page provides an overview of healthcare and pharmaceutical industry licensing in Michigan for individuals and businesses. 10. Number of containers filled. 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 Description of bill of sale, invoice, bill of lading or other document (if any). Learn More Continuing Education Provider Accreditation Click to learn more about: CE Provider Accreditation 7. 3. [See rule 31 (1A) and (1B)] (c) Identification. Pharmacy Intern Application Instructions Completed Application:Applications may be submitted online at MyLicense.IN.govor completed by paperand mailed to our office. Board shall be deemed to be an additional category of drug for the purpose of this Schedule. Ammonium Bicarbonate. (2) Kettles, steam, gas or electrically heated. Examination Procedure: 1. By way of basic Rs. Insulin. Sodium Salicylate. (i) the manufacturing premises shall be maintained properly and shall, as far as possible, be orderly , clean and free from accumulated waste and vermin; (e) one medical specialist from the Army Medical Corps. (au) "Schedule" means Schedule to these rules; General ACPE Graduate - Original License: Applicants for a pharmacist license must be at least 18 years of age; and hold a baccalaureate or doctorate degree in pharmacy from a school or college or pharmacy accredited by the Accreditation Council for Pharmacy Education. I/We of ..hereby apply for registration of the drug, namely..details of which are enclosed. In the case of operations involving floating particles of fine powder or dust, a suitable exhaust system should be provided. Granulating Section: (1) Disintegrator, where applicable. SCHEDULE B 8. or PharmD) is required to sit for the North American Pharmacist Licensure Examination (NAPLEX). [See rule 31 (10)] Name of Manufacturer. Signed (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; Rs. Precautions during cooling Its steps are mentioned as follows Firstly download and fill the prescribed form-5 in drug rules ( click this link to download ). 33. Actual production and packing particulars. Certified that following drug(s) are hereby registered under the Drugs Ordinance/Act, 1976:- Benzoic Acid. (ii) the Federal Government may, after giving an opportunity of being heard, prohibit the publication of any advertisement in any such journal as it is found to violate any of the conditions specified under sub-rule (1). 5. . (3) Cutting equipment. 4.4 Quarantine (g) "batch numbering system" means a standard operating procedure describing the details of the batch numbering; 26. 4. 1. 9.1 General 10.1 Documents Bacteriophages. 6.9.1 Testing prepared reference standard Copyright (c) PPAPAK.ORG.PK - 2020 - 2023 - Pakistan Pharmacists Association. (2) All claims concerning a drug for the purposes of promotion shall be reliable, accurate, truthful; informative, balanced, up to date, capable of substantiation and in good taste. (15) Labelling and packing benches, Graduates Pharmacist Licensure by Examination for Non-U.S. Introduction . (9) Miscellaneous. 5. (iii) Name of the drug(s) registered/approved. 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. 22. 5.1 Sanitation Sign in to start your session. (c) infants. Information for patients contained in package inserts, leaflets and booklets.- (1) Adequate information on the use of drugs shall be made available to the patients where it is necessary for rational use of a drug. (i) "biological agents" means micro-organisms, including genetically engineered micro-organisms, cell cultures and endoparasites, whether pathogenic or not; (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. (ii) Batch number(s) Sodium Metabisuphite. 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, Name and address of the manufacturer: Register Lost your Password? 1. Filed Officer will recommend or reject for establishment of pharmaceutical . SECTION -- 6 2. (3-B) Any application under sub-rule (1) or sub-rule (3) shall be accompanied by the proper fee specified in Schedule F. There should be no drains at all in plants and in warehouse. 12. (4) Water still. 27. Outside contractor Equipment maintenance I/we.of .hereby apply for registration of the drug namely details of which are enclosed. Precautions against contamination Name of all ingredients, quantities required for the batch size, quantities actually used. of tablets, injections tubes litres etc. 5.2 Hygiene 12. Address. (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; (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; (3) The members of the Central licensing Board, other than its ex officio members, shall hold office for three years and shall be eligible for renomination. (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. Application fee $10.00: Pay by credit or debit card for applications submitted online. (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. 3.3 Protection Against Insects etc. General 10.1.8 Revision of specification 67. Each state may have different individual . Central Licensing Board: (1) The Central Licensing Board shall consist of the following members, namely :-- To our office shall consist of the batch size, quantities required for North. 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