pharmacy license requirements in pakistan

6. 5. 8. (ii) If the application for renewal is made after the expiry of the period of validity of licence but within sixty days after expiry of the period validity: 1 2 3 6.4.2 Handling 44. 6.2.4 Damaged container (9) The following information shall be supplied to the Registration Board-- 17. 9.1 General B. Parenteral preparation: Date of issue .. Provided further that a person already approved by the Central Licensing Board as the production incharge of a pharmaceutical firm shall continue to be the technical supervisor of that firm for the purposes of this rule. (iii) Details of the section-wise equipment and machinery for manufacture and quality control. Date of granulation wherever applicable. 16. Invoice/Challan number and date. C.). Signed 6.10.1 Storage SCHEDULE G (b) "airlock" means an enclosed space with two or more doors, which is interposed between two or more rooms of differing classes of cleanliness for the purpose of controlling the airflow between those rooms when they need to be entered and an airlock is designed for and used by either people or goods; Schedule an inspection 10. 2. 34. Control reference numbers in respect of raw materials used. Committee on Safety of Medicines of U.K. or corresponding agencies of France, West Germany, Japan, Sweden. Toxins. Protective garments in grade B room Specifications, with details of analytical procedure for each ingredient and the finished drugs (not required in case of a drug for which pharmacopocial standards recognised under the Drugs Act, 1976, are claimed). (3-B) Any application under sub-rule (1) or sub-rule (3) shall be accompanied by the proper fee specified in Schedule F. No. Ferric Ammonium Citrate. (iii) facilities for vaccination and inoculation against the enteric or any other epidemic group of diseases; and 6.3 Packaging materials at least one person holding a degree in pharmacy, medicine, science with chemistry or chemical engineering from a university in Pakistan or any other institution, recognised by the Federal Government for the purposes of the Ordinance, and shall possess qualifications and experience which, in the opinion of the Central Licensing Board, is appropriate and adequate for the manufacture and handling of the drug to be, or being, manufactured. (ii) Testing Procedures 19. (ii) medical inspection of workers at the time of employment and periodical check up thereafter at least once a year; CERTIFICATE OF REGISTRATION Ensure contact between gas and microbial cells Licensing requirements for Michigan healthcare and pharmaceutical companies and individuals. 10. Name of drug. Validation (e) Sterility--(/) Bulk sample wherever applicable (ii) container sample. HTML PDF: 246-945-246: Wholesaler. Monitoring of clean areas A total area of not less than 900 square feet for the three Sections is required for basic installations. (x) "large-volume parenterals" means sterile solutions intended for parenteral application with a volume of more than 100ml in one container of the finished dosage form; Pharmacist-in-charge information, including license number. 7.4.5 Printing operation checks (a) the name under which the drug may be sold; (c) major precautions, contra-indications and warnings, if any; and Name(s) of Proprietor(s)/Director(s)/Partner(s). 6.1.1 Quarantine Sodium Iodide. 30. 190.00 Renewal Fee. The training shall include instructions regarding appropriate ethical conduct taking into consideration the W.H.O. (a) Generic/international non-proprietary name: [See rule 26(3A)] 53. 10. (iii) Cost of direct labour, 1,000 per advertisement. Dose and volume of solution injected into each rabbit and time of injection. (a) Building: Building should be provided with both good general ventilation and protection against direct sunlight, with easy access for fire-fighting equipment including fire-extinguishers, fire-blankets, .hose, reels and fire-alarm, etc. 10,000 4. 6. 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 :-- The Ministry of Health and Family Affairs issued the Cosmetic Rules in December 2020, which states that a drug license is mandatory for importing cosmetics into India. Actual production and packing particulars. Duration of the exam is 2 hours 3. 6. (ai) "processing instructions or procedures" means a defined in clause (ab) of this section; Washing of clothing (4) Water still. 12. 6.9.1 Testing prepared reference standard MANUFACTURE BY WAY OF FORMULATION 3.7.8 Storage of recalled drugs All arrangements for production and analysis must be in accordance with the registration and agreed by both parties. 7.2.1 Precautions against dust (3) Cutting equipment. (2) Stainless steel scoops end vessels. FIHS is registered with Pharmacy Council of Pakistan and Punjab Pharmacy Council to offer Pharmacy Technician (Category-B) professional diploma. Benzoic Acid. (4) Every drug shall be produced in sufficient quantity so as to ensure its regular and adequate supply in the market. DISEASES, ADVERTISEMENT FOR TREATMENT OF (c) experiences, investigations, studies and tests involving the chemical or physical properties or any other properties of that drug; I enclose :- 4. 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. Contract Giver (c) Recommended storage conditions and expiration date to be assigned to the specific formulation and package.. Ingredients : SECTION--2 Once approved, the agency will schedule a site inspection. Potassium Citrate. and dispensing of drugs established under (b)(7) of this section must be consistent with the requirements of secs. I/We of ..hereby apply for registration of the drug, namely..details of which are enclosed. Pharmacological group _________________________ Pharmacy Intern Application Instructions Completed Application:Applications may be submitted online at MyLicense.IN.govor completed by paperand mailed to our office. Promotion in the form of financial or material benefits shall not be offered to or sought by health care practitioners to influence them in the prescription of drugs. (5) Various liquid measures and weighing scale. Provided that such variation shall be recorded in writing with reasons therefor and also communicated in writing to the manufacturer for his record, 3.6.3 Written procedures Name of drugs with quantity to be manufactured. (c) The manufacture shall be conducted under the active directions and personal supervision of competent technical staff consisting of. (ah) "pharmaceutical product" means any drug intended for human use or veterinary use presented in its finished dosage form or as a starting material for use in such a dosage form; (b) Proprietory name, if any: Ephedrine Sulphate. Particulars regarding the precautions taken during manufacture to ensure that aseptic conditions are maintained. Batch number (if bulk lot is divided into various batches and processed separately, a batch number distinctly different from that of the bulk lot should be assigned to each of the processed batch), (3) A suitable power driven mixer. (b) The licensee shall allow a member of the Central Licensing Board or of a Provincial Quality Control Board or an Inspector to enter, with or without notice, the premises where the drugs are manufactured and to satisfy himself that the manufacture is being conducted for experimental purposes. 6.2.2 Purchase from producer or established supplier Advertisements in any form to the general public.- (1) Advertisements to the general public, where permissible, shall help people to make rational decisions on the use of drugs determined to be legally available without a prescription. Mean initial temperature of each rabbit, Licence to Manufacture (i) enclose certificate of registration and Free Sale from any of the following countries: Records of readings taken to check weight variation in case of capsules, 10.4 Batch packaging records Individuals who withdraw their licensure application may be entitled to a partial refund. Serial number. Sodium Chloride. 8. 61. The invitation letter should accurately reflect the presentations and discussions to be held. Click GO on the Apply/Manage a License and Service Requests tile. Filling and Sealing Room: Retailer's discount: The retailers discount shall be 15% of the maximum retail price. Mr./Messrs .. of is/are hereby licensed to manufacture the drug(s) specified below for experimental purposes at :. (3) Filter press or other suitable filtering equipment such as metafilter or sparklet filter or Also-pad filter. 58. 2.2 Layout (3) Polishing pan, where applicable, 10.1.10 Starting material re-assay 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). [See rule 2 (e)] (d) the approved therapeutic uses; The following equipment required :- This registration shall be valid for a period of five years unless earlier suspended or cancelled. 1.1 Responsibility of licensee for drugs fitness for use. (2). is/are hereby licensed to manufacture by way of Basic Manufacture/Semi Basic manufacture/Formulation/Repacking at the following premises:- (2) No person who is a member of the Appellate Board shall be nominated to the Central Licensing Board. 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. Initial investment (and details of equity shares). 9. (g) any failure of one or more distributed batches of that drug to meet the required specifications; Name of the drug, SECTION -- 5 or at such other place(s) at the. 6 wherever necessary. 19. in case of Hypodermic tablets and ophthalmic preparations which are required to be manufactured under aseptic conditions, records shall be maintained indicating the precautions taken during the process of manufacture to ensure that aseptic conditions are maintained, Learn More Continuing Education Provider Accreditation Click to learn more about: CE Provider Accreditation RECORDS OF RAW MATERIALS (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. Note: Particular regarding various tests applied (including reading and calculations) shall be maintained and necessary reference these records shall be entered in serial No. Sodium Salicylate. (1) Mixing and storage tanks. Protocols of tests applied: (8) The Central Licensing Board shall follow such policy directing as the Federal Government may issue from time to time. Note: Particulars regarding various tests applied shall be maintained and necessary reference to these records shall be entered serial No. Register Your Self. 14. SCHEDULE E (b) Proprietory name, if any: 6.11 Miscellaneous (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; Suitability of process (1) Mixing tanks where applicable: Use of disinfectants and detergents SECTION -- 6 9. Antigen. Frequency of use of filter SCHEDULE B-III SECTION -- 4 Requirement for Assistant Pharmacy License Holder of a recognized assistant pharmacist certificate (All weighings and measurements shall be checked initiated b the competent person in the section). 7. 7.2.4 Microbiological monitory 14. 2. 10.4.4 Recording batch numbers In case medicated dressings are to be manufactured, room with an area of minimum of 300 square feet shall be provided. Protocols of tests applied 6.2.6 Labelling 3.4.1 General Note: Particulars regarding various tests applied (including reading and calculations) shall be maintained and necessary reference to these records shall be entered in serial No. Clothing requirements (f) one pharmaceutical chemist or expert in quality control, to be nominated by the Federal Government; 10.3.2 Checking work station Central Licensing Board may from time to time permit. The walls and floor shall be such as may permit their being sprayed and washed with an antiseptic solution. Test Report number. 4. (All weighings and measurements shall be checked and initialled by the competent person in the section). 3. (viii) Light 4. (10) Rejection of an application for the registration of a drug shall not debar an applicant from submitting a fresh application under rule 26. 10. 6.6.3 Batch recovers 4.1 General 56. ----------------------- The drug(s) or class(es)of drugs intended to be continued to be manufactured:- 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: Hygiene and cleanliness Nebraska Governor Pete Ricketts recently signed Executive Order No. . 5. FORM-5B Analytical report number. (e) "batch (or lot)" means a defined quantity of starting material, packaging material, or finish product processed in a single process or series of processes so that it could be expected to be homogeneous in the case of continuous manufacture the batch must correspond to a defined fraction of the production, characterized by its intended homogeneity, and to complete certain stages of manufacture it may sometimes be necessary to divide a batch into a number of sub-batches, which are later brought together to from a final homogeneous batch; (c) For pyrogens wherever applicable. (3) Advertisements under sub-rule (2) shall be subjected to the following conditions, namely :-- (2) Ampoule washing and drying equipment. 4.6 Rejected Materials Sodium Bicarbonate. 3. (2) Trimming machine. 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. GOVERNMENT OF PAKISTAN 2. Soft yellow Paraffin. Licensing Authority. 23. [See rule 26 (3)] For this purpose, it is desirable that each tablet machine is connected either to an exhaust system or isolated into cubicles. (6) A licensee who for any purpose is engaged in the culture or manipulation of pathogenic spore bearing micro-organisms shall provide, to the satisfaction of the Central Licensing Board, separate laboratories, utensils and apparatus required for the culture or manipulation of such .micro-organisms, and they shall not be used for the manufacture of any other substance. Licenses State Board of Pharmacy Permit Drug Enforcement Administration (DEA) Number National Provider Identifier (NPI) Number Harrisburg, PA 17105-2649. (a) For the grant of licence: ADDITIONAL CONDITIONS FOR MANUFACTURE OF STERILE PRODUCT Omitted vide S.R.O. of USA. (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. (3) Substantiated information on hazards associated with the drug shall be reported to the Registration Board as a priority. 6. 13. (See rules 19 and 30) 7.3.5 Yield deviations 8. 8. 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. 33. PREMISES Manufacture on more than one set of premises: If drugs are manufactured on more than one set of premises, a separate application shall be made and a separate licence shall be issued in respect of each such set of premises. 8. 3.1 General 3. SECTION -- 5 Drug Regulatory Authority of Pakistan. [See rule 21(3)] 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. (c) rupees two hundred and fifty for the renewal of the registration of a new or any other drug: (b) For the renewal of licence The text shall be fully legible. Bio-availability studies: (i)one copy of each issue of such journal or publication is sent to the Drug Administration of the Health Division; and Signature of Analyst, 4.6 Packaging Instructions If you have an active intern registration in Kansas, you may only need to pay $100. (e) Signs: Signs indicating smoking restrictions, location of emergency kits, fire-fighting equipment, telephone end escape routes must be prominently displayed. I/We . of hereby apply for the renewal of a licence to manufacture by way of on premises situated at Aseptic Filling and sealing room: 2. 6.3.3 Reference numbers Pharmacy Services Health Department KP. {4) Heater and exhaust system, where applicable. 7. Calcium Gluconate. This page provides an overview of healthcare and pharmaceutical industry licensing in Michigan for individuals and businesses. (c) Any other tests Undertaking to manufacture drug locally within two years. The room shall be further dehumidified if preparations containing antibiotics are manufactured. Salicylic Acid. 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. (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. (a) Clarity, (ak) "purity" means the degree to which other chemical or biological entities are present in any substance; 3.3.7 Stability studies The well-qualified teachers help the students to develop skills needed to pass the examination. 4.8.3 Specific training Medical representative shall not offer inducements to prescribers and dispensers. 4.9.2 Practices in personal hygiene By way of formulation Rs. (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; 6.2.1 Purchase 6.6.4 Additional testing of reprocessed materials For the procedure to withdraw your application, contact the Pharmacy Unit at opunit1@nysed.gov or by calling 518-474-3817 ext. (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. 1. (at) "returned product" means finished product sent back to the manufacturer or distributor; This Executive Order relates to criminal background checks by fingerprint and only affects licensing for audiologists, speech-language pathologists, licensed independent mental health practitioners, occupational therapists, and occupational therapy assistants. (iv) Services ENCLOSURES OF THE APPLICATION FOR REGISTRATION OF A DRUG Duration of certificate of registration: A certificate of registration under this chapter, shall, unless earlier suspended or cancelled, be. (b) PH wherever applicable, 5. 68. (g) the Drugs Controller, Ministry of Health, Government of Pakistan who shall be its ex-officio Secretary; By way of repacking Rs. 15. Solution of serum proteins intended for injunction. 4. 2.5 Tanks . 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. 5. (b) Identification. 6.2.7 Identity of contents The benches shall preferably have stainless steel or laminated plastic tops capable of being washed. 9. 7.1.8 In price controls 14. Additional conditions of licence to manufacture drugs by way of formulation: A licence to manufacture drugs by way of formulation shall, in addition to the conditions laid down in rule 19, be subject to the following further conditions, namely :-- 4.4 Manufacturing, analytical and distribution records and reference samples shall be kept by, or be available to, the contract giver, and any records relevant to assessing the quality of a product in the event of complaints or a suspected defect shall be accessible and specified in the defect or recall procedures of the contract giver. (g) The applicant shall provide-- 1.2 General.-- Contract production and analysis shall be correctly defined, agreed and controlled in order to avoid misunderstandings that could result in a drug or work or analysis of unsatisfactory quality. Note: The registration fee will change to $35 on September 1, 2021 and will be in effect until June 1, 2022. (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-- Sodium Metabisuphite. 1. Any individual, LLP, partnership firm, OPC or company can apply for a drug license. An area of minimum of 300 square feet is required for basic packing operations. Summed response, (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. 6.1 Material, general Records of test to be carried out in case of tablets as under An area of minimum of 200, square feet required far the basic installation, 1. Temperature of each rabbit noted at suitable intervals, The profit margin of retail pharmacies or medical stores ranges from 15 20 to 20% for each product. The room shall be air-conditioned and also dehumidified wherever necessary. 4.9.7 Foods and drinks prohibited 3.1 Quality Control Department Phone - (717) 783-7156. 3, Batch number Protocols of tests applied: Certified that following drug(s) are hereby registered under the Drugs Ordinance/Act, 1976:- (d) Sterilisation. 4. [See rule 26(I)] You'll also need to pass The North American Pharmacist Licensure Exam (NAPLEX) in order to practice in every state. 2.3 Products sterilized by filtration Name, address and status of the applicant: State Board of Pharmacy. General (6) A record of quarterly production and disposal of a drug shall be maintained and supplied to the Chairman of the Registration Board in Form 7 in the months of January, April, July and October each year. Equilibrium with humidity and temperature 08.80.040 . 63. 3.7.2 Authorized procedures sealing unit, SECTION-1 (7-A) The indenter, importer or manufacturer's authorised agent shall issue a warranty in Form 2-A for any drug indented or sold by him for the purpose of re-sale or distribution; and 25. 1.6 In the case of contract analysis, the final approval for release must be given by the authorised person(s). Compound Effervescent Salts, [--] , Milk of Magnesia. (b) Wells: Walls as far as possible should be protected by non-flammable or slow burning material. SECTION-I (5) Pessary and tablet counter. (d) Uniformity of diameter (if applicable). The drug(s) or class(es) of drugs intended to be manufactured :- (iii) Name of the drug(s) registered/approved. 32. 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:- ST-PHARMACY@PA.GOV. Methylene Blue. SCHEDULE D-I Water supply (4) Stainless steel vessels and scoops of suitable material, (d) Volume in container, 11. (5) Mixing and preparation tanks or other containers. (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; Calamine. Previously, an applicant or proprietor had to go to the Secretary's office of the District Quality . HTML PDF: 246-945-245: Health care entity license. sub-rule (8); and 7. 7. (6-A) The quorum to constitute a meeting of the Board shall be one third of its total membership. 277 (1)/96 dated 2 lst April 1996. (a) Average weight every thirty minutes. General 7.3.7 Water pipes Form-7 License: This type of Drug sales license should be used for the sales of Medicines for Importers, Exporters, Indentors and Manufacturers. Pharmacy Licensing | Washington State Department of Health Thank you for your patience as we continue to update our new website. Building Design And Construction (General) Non-Proprietary name: [ See rule 26 ( 3A ) ] 53 the.... To ensure its regular and adequate supply in the section ) 9 ) the to... Offer Pharmacy Technician ( Category-B ) professional diploma a total area of not than... Of drugs established under ( b ) ( 7 ) of this section must be given the... Serial No numbers in respect of raw materials used b ) ( 7 ) this. An area of not less than 900 square feet is required for installations... Control reference numbers in respect of raw materials used and status of maximum. Walls and floor shall be further dehumidified if preparations containing antibiotics are manufactured of. Schedule a site inspection ) the following information shall be produced in sufficient quantity so as ensure. The competent person in the case of contract analysis, the agency will schedule site! Drug locally within two years and status of the applicant: State Board of Pharmacy drug! 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( 6-A ) the quorum to constitute a meeting of the District Quality 246-945-245: Health care entity license Parenteral... ) 783-7156 filter or Also-pad filter that aseptic conditions are maintained to manufacture the drug ( s specified! Of Health Thank you for your patience as we continue to update our new website person in section. Consideration the W.H.O way of formulation Rs ( d ) volume in container, 11 with... Ingredients: section -- 2 Once approved, the final approval for release must given... Filter press or other suitable filtering equipment such as may permit their being sprayed and washed with antiseptic! This section must be consistent with the drug shall be reported to the Board! Department Phone - ( 717 ) 783-7156 Applications may be submitted online at MyLicense.IN.govor Completed by paperand mailed to office. Not offer inducements to prescribers and dispensers provides an overview of healthcare and pharmaceutical licensing... 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The Secretary & # x27 ; s office of the Board shall be checked and initialled by the person... Approved, the final approval for release must be given by the competent person the... Benches shall preferably have stainless steel vessels and scoops of suitable material, ( d ) Uniformity of diameter if. Steel or laminated plastic tops capable of being washed, ( d ) volume in container,.! Of raw materials used sample wherever applicable ( ii ) container sample committee on Safety of Medicines of U.K. corresponding. Into each rabbit and time of injection prohibited 3.1 Quality control Department Phone - 717. Ensure its regular and adequate supply in the case of contract analysis, agency! Shall be supplied to the Registration Board -- 17 Board as a.. Pharmacy Council of Pakistan and Punjab Pharmacy Council to offer Pharmacy Technician ( )...: Retailer 's discount: the retailers discount shall be supplied to the specific formulation package! 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