HTML PDF: 246-945-233: Hospital pharmacy associated clinics. 33. Vaccines. (5) Any fee deposited under sub-rule (2) Shall in no case be refunded. (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. 7.3.8 Equipment calibration Entry restricted 46. Note: The registration fee will change to $35 on September 1, 2021 and will be in effect until June 1, 2022. 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. 6. (iii) any foreign qualification the quality and content of the training of which are comparable with those described in sub-clause (i) or sub-clause (ii) and is approved for the purposes, of this sub-rule by the Central Licensing Board: Provided that the Central Licensing Board may, in the case of manufacture of drugs included in Schedule C, permit the manufacture of such drugs under the active direction and personal supervision or a person holding a degree in medicine or veterinary sciences of a university in Pakistan or any other institution recognised by the Federal Government, with at least three years experience in the manufacture, testing and analysis of biological products which are intended to be produced: 10.4.6 Finished product release procedure (b) PH wherever applicable, (3) Employers shall be responsible for the statements and activities of their medical, representatives. (v) licence to manufacture for experimental purposes. 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. 6. 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. Name of the Firm. 3.7.3 Written procedures Provided further that the Central Licensing Board, may, in the case of anufacture of disinfectant fluids, insecticides liquid paraffin, medicinal gases, non-chemical contraceptives, plaster of paris, surgical dressing or chemicals for the manufacture of which the knowledge of pharmacy or pharmaceutical chemistry is not essential, permit manufacture of the drug under the active direction and personal supervision of competent staff who, [..] has in the opinion of the Central Licensing Board, adequate knowledge and experience in the manufacture of the drug (s) to be produced. 18. 13. 45.00 Initial Fee. 59. Air Classification system for manufacture of sterile products 6.3 Packaging materials (g) Toxicity test, wherever applicable. Care for biological indicators (ii) medical inspection of workers at the time of employment and periodical check up thereafter at least once a year; (I) The following equipment is required for the manufacture of inhalers end Vitrallae: Gripe Waters. The Tableting Section shall be free from dust and floating particles. This registration shall be valid for a period of five years unless earlier suspended or cancelled. (iii) licence to manufacture by way of formulation; 10.2 Specification for intermediate and bulk products (c) two pharmacologists, to be nominated by the Federal Government. 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. 3.4 Surfaces Antigen. 3.7.8 Storage of recalled drugs 4.8 Training (v) Storage Calamine. 7.4.10 Discrepancies to be investigated 4. 21. 2. (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. SECTION -- 3 6.6.2 Reprocessing (i) the name and address of manufacturer or distributor; [--] (3) Antiseptics and disinfectants for household use, excluding those containing hormone and antiniotics. 6.3.1 Purchase Initial investment (and details of equity shares). Bioburden to be minimal (i) Name of the proprietor/directors/partner(s) By way of repacking Rs. (2) Capsule filling units. Apply for insurance 11. Dosage form of the drug: WV Board of Pharmacy 1207 Quarrier Street, 4th Floor Charleston, WV 25301 Phone: 304-558-0558 Fax: 304-558-0572 Email: Contact Form | boardofpharmacy@wv.gov Alniminium Hydroxide Gel Dried. (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; 4. 6. Fax - (717) 787-7769. Pharmacy Technician (Category-B) diploma holder is eligible to apply for license to open own medical store. (d) The applicant shall establish an independent Quality Control Department and maintain separate staff, premises and adequate laboratory equipment for carrying out tests of the strength, potency, quality and purity of the substances being or to be used in the manufacture. Analytical report number. ADDITIONAL CONDITIONS FOR MANUFACTURE OF STERILE PRODUCT 17. 1. 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 :-- An area of maximum 300 square feet is required for the basic installations. 19. (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. Gentian Violet. Storage Areas 7. (a) Average weight every thirty minutes. SECTION--2 Bismuth Subnitrate. 21. Pharmacy Miscellaneous Permit (Out-Of-State Pharmacies) License. Records of sterilisation in case of parenteral preparation which are heat sterilised including particulars of time temperature and pressure employed. Nebraska Governor Pete Ricketts recently signed Executive Order No. Whether the drug is registered for local manufacture or import (4) Water still. C.). Ephedrine Hadrochloride. 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. (1) Sifter. Frequency of use of filter While advertisements shall take account of peoples legitimate desire for information regarding their health they shall not take undue advantage of peoples concern about their own health. Any individual, LLP, partnership firm, OPC or company can apply for a drug license. 10.4.10 Equipment utilization record (3) Punch and dyes storages cabinet. ENCLOSURES OF THE APPLICATION FOR REGISTRATION OF A DRUG APPLICATION FOR LlCENCE TO MANUFACTURE DRUG(S) FOR EXPERIMENTAL PURPOSES. (2) A drug or any substance referred to in clause (ii) of Sec. (t) "good manufacturing practices for pharmaceutical products" means part of quality assurance which:-- (c) the statement of all the representations to be made for the promotion of the drug in respect of-- This room shall be air-conditioned. Secretary, Central Licensing Board. SECTION -- 6 3.6.8 Review for Reviewing Problem This page provides an overview of healthcare and pharmaceutical industry licensing in Michigan for individuals and businesses. The NAPLEX is one component of the licensure process required to practice as a pharmacist. _________________________ 2.8 Defective Equipment 8. Filtration of pharmaceutical products that cannot be sterilized in the final container Following statement, as per audited accounts/based on Income Tax Return for the last five years:- Issuance of a drug-sales license or pharmacy license is a procedure given by the Pharmacy council of Pakistan (PCP). 13. Salicylic Acid. FORM 2 Care after final cleaning of materials 113-54 (Drug Supply Chain Security Act). 31. (b) the Director, Health Services of, each Provincial Government; (8) Contraceptives. 6. (h) major interactions; (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. 10,000 10,000 6.6.1 Storage and disposal 63. [See rule 20 (b)] The benches shall preferably have stainless steel or laminated plastic tops capable of being washed. Analytical report number. Statement of the Central Research Fund. SECTION--2 Provided that the Central Licensing Board may allow a portion of such contribution to be spent by the firm itself for research and development of new drugs or for establishing research laboratories when it is fully satisfied that such expenditure will be utilised for the said purpose effectively and properly. P.O. (C) The licensee shall comply with such further requirements, if any, as may be specified under any rule subsequently made. or PharmD) is required to sit for the North American Pharmacist Licensure Examination (NAPLEX). An area of minimum of 300 square feet is required for the basic installations. (2) An application under sub-rule (1) shall be accompanied by the proper fee as specified in Schedule F. 50.00 stamp papers as prescribed ( Click to Download- Affidavit) Form-5 (Click to Download) 2) Follow the instructions provided and fill out an affidavit on papers with a Rs.50.00 stamp ( Click to Download- Affidavit ) 3) Make a deposit in a bank . (2) They shall come into force at once. (i) the manufacturing premises shall be maintained properly and shall, as far as possible, be orderly , clean and free from accumulated waste and vermin; Proposed shelf life with storage conditions, if any : (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). I enclose :- 2.2 Layout Date .. 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. 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. (3} Granular (r) "Form" means a form set forth in Schedule A; (2) Moulding equipment. (Signature of designated authority (Place and date) Have a desire to help 2. Pharmacological and clinical data : 68. Sufficient time allowed to reach required temperature (6-A) The quorum to constitute a meeting of the Board shall be one third of its total membership. 41. Date of filling. Results and remarks, (8) The Central Licensing Board shall follow such policy directing as the Federal Government may issue from time to time. To get a medical store license, you must complete a 2-year Pharmacy Technician B Category diploma. 8. This sort of license may be found here. (au) "Schedule" means Schedule to these rules; 3.1 General (2) In addition to approved package inserts and leaflets wherever available the preparation and distribution of booklets and other information material for patients and consumer shall also comply with the ethical criteria enunciated in this schedule. SECTION--3 STATEMENT SHOWING QUARTERLY PRODUCTION TO BE SUBMITTED IN DUPLICATE GOOD MANUFACTURING PRACTICES (GMPs) FOR LICENCE TO You will find state requirements, application fees, filing instructions, and more. (5) A calloid mill or a suitable emulsifier or homogeniser, where applicable. 4. 23. degree from a college accredited by the Accreditation Council for Pharmacy Education (ACPE). In case of a new drug (entity) not yet registered in Pakistan : Pack size. (iii) Details of the section-wise equipment and machinery for manufacture and quality control. 54. (c) Uniformity of weight. 4.8 S.O.Ps for Testing (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; The drug(s) or class(es)of drugs intended to be continued to be manufactured:- 5.2 Dedicated Facilities for Production Pharmacist Exam and License. (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. 22. 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. how to apply dha exam for pharmacist. 9. Note//: This Schedule gives equipment and space required for certain categories of drugs only. Personnel training Contract production and analysis (b) For the renewal of licence 27. 7. 871(I)/78, dated 8th July, 1978.] Checking integrity of filters PRACTICE OF PHARMACY AS A PROFESSION. (1) Mixing tanks where applicable: 9. 5. 3.3.5 Test Requirement for Finished Products (6) Antacid and carminatives: 20A. (q) "finished product" means a product that has undergone all stages of production, including packaging in its final container and labeling; (ii) Details of the premises including layout plan of the factory. 4.12 Batch processing records 4.1 General (a) rupees one thousand for the registration of new drug; (h) Any other teats. Ferrous Sulphate. Number of container packed CONDITIONS FOR GRANT OF A LICENSE TO MANUFACTURE BY WAY OF FORMULATION APPLICATION FORM FOR REGISTRATION OF A DRUG FOR LOCAL MANUFACTURE 3.6.6 Follow-up action APPLICATION FORM FOR RENEWAL OF REGISTRATION OF ALL KINDS OF DRUGS (2) No person who is a member of the Appellate Board shall be nominated to the Central Licensing Board. 6. Equipment maintenance 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. In order to gain the license to practice pharmacy, applicants will be required to complete two stages of examinations. (2) Graduated delivery equipment for measurement of the medicament. 5. (4) If the Central Licensing Board is not so satisfied, it shall reject the application and shall inform the applicant of the reasons for such rejection and of the conditions which must be satisfied before a licence may be issued. Area FID/Field Officer of Drug Regulatory Authority of Pakistan (DRAP) will inspect proposed site if fulfillment of pre requisites documents finds in submitted application. (ii) licence to manufacture by way of semi-basic manufacture; 8. and (3) Reminder advertisements shall include, amongst others, at least the international non-proprietary name or generic name, the name of each active ingredient and the price of drug and the name and address for the manufacturer or distributor for the purpose of receiving further information. 18. 10. PART-I Use of vacuum Control reference numbers in respect of raw materials used. Place.. Name, designation and address 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. There are, in addition, other categories such as drugs miscellaneous pharmaceuticals such as Ferries Ammonii Citras. 60. The application fee is $147. (4) In the room provided for aseptic filling and sealing, necessary measures for maintaining sterility and to preventing contamination shall be adopted. SECTION -- 4 Name of the registered drug, with its registration number and date or initial ,registration and last renewal ' (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. (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. Ferric Ammonium Citrate. Bismuth Carbonate. Sodium Thiosulphate. Interval between operations to be minimal (d) Uniformity of diameter (if applicable). Biological indicators 4.9.3 Illness (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. Batch number. (c) Recommended storage conditions and expiration date to be assigned to the specific formulation and package.. Opinion and signature of the approved Analyst. Form-7 License: This type of Drug sales license should be used for the sales of Medicines for Importers, Exporters, Indentors and Manufacturers. 3.4 Facilities (i) Particulars regarding the legal status of the applicant (i.e. (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. (1-C) The approval of the advertisement, granted under sub-rule (1), shall be valid for a period of two years only. 6.4 Intermediate and bulk products in Pharmacy. Sterilized surgical lignature and sterilized surgical suture. 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. (d) special groups, (2) An application under sub-rule (1) shall be countersigned by the head of the institution in which,. (i) Granulating Section; (c) Any other tests 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. 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