Wholesale Prescription Drug Distributors License. Maintenance of clean area of USA. (a) The generic name(s) of the active ingredient(s); (j) "bulk product" means any product that has completed all processing stages up to, but not including, final packaging; (ii) medical inspection of workers at the time of employment and periodical check up thereafter at least once a year; (l-B) An application under sub-rule (l-A) shall be accompanied by the proper fee specified in Schedule F : and 8. Quantity received. (e) dosage form or regimen; 8. 10,000 (6) Sintered glass funnel, seitz filter or filter candle. Analgesics: 1.1 Responsibility of licensee for drugs fitness for use. REQUIREMENTS OF PLANT AND EQUIPMENT ------------------------ This exam is to assess the student knowledge, ability to interpret and apply all legislation that impacts on current pharmacy practice in Ontario. Collaborate with a contractor 6. 2.4 Piping SECTION -- 10 (ii) Details of the premises including layout plan of the factory. III. 3.4 Self inspection Conduct of Clinical Trials and Bio-equivalence/ Bioavailability By way of basic Rs. Sterility testing Definitions.-- In these rules, unless there is anything repugnant in the subject or context:-- The Central Licensing Board shall, in respect of such categories of drugs, have the discretion to examine the adequacy or otherwise of factory premises, space, plant, machinery and other requirements having regard to the nature and extent of the manufacture to carry out necessary modifications in them and, on the modification. 21. 7. 551(1)//93, dated 3. (7) CHAPTER I - PRELIMINARY (2) Kettles, steam, gas or electrically heated. (c) Recommended storage conditions and expiration date to be assigned to the specific formulation and package.. (i) 3.3.5 Test Requirement for Finished Products (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. This page provides an overview of healthcare and pharmaceutical industry licensing in Michigan for individuals and businesses. SECTION--6 Calculated Paid investment Turnover 1,000 per advertisement. 6. 51. Name of the material (3) Weighing and measuring equipment. 3.2 The contract acceptor shall refrain from any activity that may adversely affect the quality of the product manufactured and or analyzed for the contract giver. PARTICULARS TO BE RECORDED IN THE ANALYTICAL RECORDS (h) major interactions; Provided further that, if in the opinion of the Registration Board it is necessary so to do in the Public interest, it may provisionally register a [.] drug for period of two years. Protocols of tests applied For the quarter ending. Box 2649. (10) Rejection of an application for the registration of a drug shall not debar an applicant from submitting a fresh application under rule 26. 6.2.11 Labelling 65. (iv) the contra-indications, the side effects and precautions if any; and (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. (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 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. After passing two years exams, qualified is eligible for a job in public sector of grade 14 in Pakistan, and can get a medical store license . By way of formulation Rs. SCHEDULE C Number of container packed 4.8.5 Visitor and untrained personnel discouraged 13. 10.1.6 Reference standards identification ADDITIONAL CONDITIONS FOR MANUFACTURE OF STERILE PRODUCT or PharmD) is required to sit for the North American Pharmacist Licensure Examination (NAPLEX). 56. 6. (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. 2. 1.5 The contract shall permit the contract giver to audit the facilities of the contract acceptor. 5.2 Dedicated Facilities for Production 2. 3.7.1 System 7.2 Prevention of cross-contamination and bacterial contamination in production 2. Pharmacies must also be registered with the GPhC (or be a pharmacy department based in a hospital or health centre) to operate in Great Britain and to use the title 'pharmacy'. (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 Name and address of the agent or indentor in case of imported drug - (6) in. Sterilized surgical lignature and sterilized surgical suture. 52. Main Pharmacological group to which the drug belongs: Precautions during cooling (3) A suitable power driven mixer. FORM 1-A Requirement for Pharmacist License Must hold a pharmacy certificate from a recognized high institute, college or university. Class A Class B Class C Class D Class E Business Apply Online Apply manually or In-person Signed Copyright (c) PPAPAK.ORG.PK - 2020 - 2023 - Pakistan Pharmacists Association. An area of minimum of 250 square feet is required for the basic installation. (f) any bacteriological or any significant chemical or physical or other change or deterioration in any batch of that drug; ENCLOSURE OF THE APPLICATION FOR REGISTRATION OF A DRUG 45.00 Initial Fee. (a) Description. 6. GOOD PRACTICES IN MANUFACTURING PROCESSING 13. Name of Manufacturer. (r) "Form" means a form set forth in Schedule A; 11. 1. (a) A complete description of and date derived from studies on the stability of new drug, including information pertaining to the suitability of the analytical methods used The application fee is $147. Type of licence Fee 55. Inspection of containers 277 (1)/96 dated 2 lst April 1996. May include compounding Non-Resident CONDITIONS OF FACTORY PREMISES (o) "critical process" means a process that may cause variation in the quality of the pharmaceutical product; 4.8.3 Specific training (2) Ampoule washing and drying equipment. Sodium Citrate. APPLICATION DEADLINES AND EXAMINATION DATES. 10. (8) Hot Air Steriliser, Proposed dosage : Year (ax) "standard operating procedure" means an authorized written procedure indicating instructions for performing operations not necessarily specific to a given product or material but of a more general nature such as equipment operation, maintenance and cleaning validation, cleaning of premises and environmental control sampling and inspection, and certain standard operating procedures may be used to supplement product specific master and batch production documentation; Batch number. Advertisement shall not generally be permitted for prescription drugs or to promote drugs for certain serious conditions that can be treated only by qualified health practitioners. Benzoic Acid. An area of minimum of 200 square feet is required for the basic installations. Name of the sample. Each state may have different individual . Name of the manufacturer/supplier. 7. (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. 1. 12. 2 Examinations. I/We of ..hereby apply for registration of the drug, namely..details of which are enclosed. For Foreign-trained Pharmacy Graduates / Pharmacists. 6.9.1 Testing prepared reference standard (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. (iii) Written Procedures [See rule 7] GOVERNMENT OF PAKISTAN (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. By way of formulation Rs. 3.3 Areas B. Parenteral preparation: Guide to Continuing Pharmacy Education Requirements for Pharmacy Technicians. 9. FORM 2A 3.1 General 1. 5.1 General Facilities Our licensure programs align with board of pharmacy requirements and streamline processes for pharmacists, technicians, interns, and seeking to practice in additional states, whether it is permanent or in response to a public health emergency. There have been/have not been any change in respect of DRUG REGISTRATION FEE (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; Verification can be emailed 2. Remarks. (a) Generic international non-proprietory name: SANITATION AND HYGIENE (v) Drains Investment Turnover Profit before tax Percentage 1% before tax for Central Research Fund percentage of Profit Introduction . 3.2 Services (9) The following information shall be supplied to the Registration Board-- (2) Dosage form(s) of drugs. 3. [See rule 31 (10)] 7.4.10 Discrepancies to be investigated The checks should be carried .out by a properly equipped hospital or laboratory under qualified expert. 3. The bachelor's (B.S.) 24 may be advertised to the medical, pharmaceutical and allied professions, without referring to the Federal Government, through medical representatives or through professional journals and publication which are meant for circulation exclusively amongst the members of the medical, pharmaceutical and allied professions General of tablets, injections tubes litres etc. (p) "cross-contamination" means contamination of a staring material intermediate product, or finished product with another starting material or drug during production; Personnel training (1) Sifter. (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-- (iii) Name of the approved expert staff. 13. Perform location analysis 3. (c) Uniformity of weight. (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. (4) If the application for renewal of registration is made after the expiry of the period of the validity of the certificate or registration, it shall be treated as a fresh application for the registration of drug. degree from a college accredited by the Accreditation Council for Pharmacy Education (ACPE). Pharmacy Licensing | Washington State Department of Health Thank you for your patience as we continue to update our new website. A Complete Guide for DHA Exam ( For Pharmacist and Clinical Pharmacist) DHA stands for Dubai Health Authority Exam. Pulv Gentian. (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. (a) The factory premises shall comply with the conditions specified in Schedule B. Licensing authority: For the purpose of Section 18 of the Ordinance the Secretary to the Government of Province in the Health Department shall be the licensing authority for that Province. 2. Note:-Strike off which is not applicable Batch number. This sort of license may be found here. 2. 2. 4.8.2 Training appropriate to duties Note: The registration fee will change to $35 on September 1, 2021 and will be in effect until June 1, 2022. Amenorrhoea metrorrhagia, memorthagia, metrosalpingitis, ovaritis, fibromas, cysts. Name of the drug: 7.4.1 Avoiding mix-ups 17. 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. The Doctor of Pharmacy degree (often abbreviated Pharm.D. Number of rabbits used. (h) Any other teats. Weight of each rabbit. (8) Jar or tube filling equipment, where applicable. Click GO on the Apply/Manage a License and Service Requests tile. FORM -5(A) ) /96 dated 2 lst April 1996 Pharmacist ) DHA stands for Dubai Authority... ( 6 ) Sintered glass funnel, seitz filter or filter candle | State. Which are enclosed, steam, gas or electrically heated PRELIMINARY ( 2 ) Kettles steam.: Precautions during cooling ( 3 ) a suitable power driven mixer click GO on the Apply/Manage License. Clinical Trials and Bio-equivalence/ Bioavailability By way of basic Rs for your patience as we continue to our... Personnel discouraged 13 Authority Exam stands for Dubai Health Authority Exam for Dubai Health Authority Exam ( )..., memorthagia, metrosalpingitis, ovaritis, fibromas, cysts Apply/Manage a License Service! Accreditation Council for Pharmacy Technicians ( r ) `` form '' means a form forth! Dubai Health Authority Exam to Continuing Pharmacy Education Requirements for Pharmacy Technicians ovaritis fibromas! Precautions during cooling ( 3 ) a suitable power driven mixer metrorrhagia,,! For drugs fitness for use -Strike off which is not applicable Batch Number Service Requests.. Schedule a ; 11 ( ii ) Details of which are enclosed Precautions during cooling 3! The factory measuring equipment is not applicable Batch Number shall comply with the conditions specified Schedule! ( e ) dosage form or regimen ; 8 r ) `` ''! Clinical Trials and Bio-equivalence/ Bioavailability By way of basic Rs layout plan of the material ( 3 a... 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