22. General 1. FORM -5(A) . (5) The Registration Board may, while registering a drug under sub-rule (4), approve the details as supplied by the applicant or approve them with amendments as it may deem fit in respect of the following particulars, namely :-- 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: 4.5 The contract shall describe the handling of starting materials, intermediate and bulk products and finished products if they are rejected and it shall also describe the processing of information if the contract analysis shows that the tested product must be rejected. : 6, Results of tests applied. (2) Where inspection under sub-rule (1) is carried out by a sub-commmittee or panel of experts of Inspectors appointed under the said sub-rule it shall forward to the Central Licensing Board a detailed report of the result of the inspection. 6. Tableting Section: 7.2.2 Measures against contamination (ac) "master record" means a document or set of documents that serve as a basis for the batch documentation (blank batch record); 3. (iii) Details of the section-wise equipment and machinery for manufacture and quality control. Sulphonilamide Powder (B. VET. Certified that following drug(s) are hereby registered under the Drugs Ordinance/Act, 1976:- 10.4.5 Analytical records 190.00 Renewal Fee. Maximum temperature. (3) Antiseptics and disinfectants for household use, excluding those containing hormone and antiniotics. (c) infants. (a) Clarity, (4) Folding and pressing machine for gauze. 4.1 General (j) "bulk product" means any product that has completed all processing stages up to, but not including, final packaging; (3) The filling and sealing rooms shall likewise be air-conditioned under positive pressure with air locks provided to. 6. 13. 4.3 The contract shall be describe clearly who is responsible for purchasing, testing and releasing materials and for undertaking production and quality controls, including in-process controls, and who has responsibility for sampling and analysis, and in the case of contract analysis, the contract shall state whether or not the contract acceptor shall take samples at the premises of the manufacturer. Sodium Iodide. The License can be renewed as it is valid for up to five years. 21. Duration: 2 years, annual system, NTS based examination Eligibility: (6) For the manner and conduct of the meetings of the Registration Board, the provisions of sub-rules (3), (4), (5), (6), (7), (8), and (9) of rule 8 shall mutatis mutandis apply. (2) Granulator. 13. This sort of license may be found here. An area of minimum of 250 square feet is required for the basic installation. Date of granulation wherever applicable. (c) the generic name(s) of other ingredient(s) known to cause problem(s) Control reference numbers in respect of the lot of glass containers used for filling. (c) toxicity or the side-effects. 45.00 Initial Fee. 26. (9) No drug or any other substance shall be advertised in a manner which encourages self-medication or use to the extent that it endangers health. 4.1 General 1.Analytical report number 3. (an) "quarantine" means status of starting or packaging materials intermediate, or bulk or finished products isolated physically or by other effective means while a decision is awaited on their release, rejection, or reprocessing; Yes, the physician must obtain from the Board of Pharmacy a license to dispense. After the DHA have pre-evaluated your documents, they will send you an email that contains the link to have your Primary Source Verification done. Water supply 2. (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: 45. Note//: This Schedule gives equipment and space required for certain categories of drugs only. 2. 68. (c) The manufacture shall be conducted under the active directions and personal supervision of competent technical staff consisting of. 6. Sanitation [See rules 28 and 29(4)] (4) Storage tanks or pots. 3.3.5 Test Requirement for Finished Products Potassium Iodine. (av) "semi-basic manufacture" means manufacture from an intermediate substance of a drug to be used as a starting material for the formulation of a finished drug or to be used for repacking; Records of tests employed :-- Mr./Messrs .. of is/are hereby licensed to manufacture the drug(s) specified below for experimental purposes at :. 9. Pack size (s) and proposed maximum retail price with the following details:- 5. The benches shall preferably have stainless steel or laminated plastic tops capable of being washed. 4.5 Master Formula 50. QUALITY CONTROL DEPARTMENT *The whole course must be done in the campus of the University/Country . 3.4 Surfaces Patent number, if any, with date and its date of expiry : 10.4.6 Finished product release procedure 12. SECTION -1 (b) The licensee shall record in Schedule B-Ill the particulars of manufacture of each batch of drugs manufactured by him and shall retain such records, in the case of a substance for which expiry date is fixed for a period of two years from the expiry of such date and, in the case of other substances, for a period of five years from the date of manufacture. 3.7.8 Storage of recalled drugs 2. 18. [See rule 21(3)] Licence to manufacture drugs for experimental purposes: (1) If a person intending to manufacture a drug for experimental purposes does not hold a licence to manufacture drugs, he shall before commencing such manufacture, apply in Form 3 for the grant or renewal of a licence to the Central Licensing Board addressed to its Secretary. (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. 1362(I)/96-28.11.96). Harrisburg, PA 17105-2649. sealing unit, SECTION-I Fax - (717) 787-7769. This room shall be air-conditioned. 3.7.5 Distribution records 1. Monitoring water supply of sources Name and address of the manufacturer: (z) "manufacturer" means a company that carries out at least one step of manufacture; Sign in to start your session. (i) Granulating Section; Don't have an Account? 9. APPLICATION FORM FOR REGISTRATION OF AN IMPORTED DRUG General 3, Batch number (ar) "retail sale" means a sale other than wholesale; 5,000 3. Requirements for a pharmacy permit vary by state, but many permit applications ask for: The type of pharmacy (Retail, Hospital, Sterile Compounding, Nuclear, etc.) The Centralized Drug Sale Licensing-Public Portal (CDSL-PP) was established for the ease of doing business (EODB), and an applicant/proprietor can apply online for a New, Renewal, or Change of Title, Address, or Qualified Person of an existing Drug Sale License using the CDSL-PP. 4.9 Weighing Area 13. (2) Trimming machine. (a) the Director-General Health, Government of Pakistan, who shall be its ex-officio Chairman; Dated (Signed) In case of a new drug (entity) not yet registered in Pakistan : 6.9.1 Testing prepared reference standard (1) Mixing tanks where applicable: Sodium Metabisuphite. Pharmacists measure and sell prescription drugs. 19. (f) "batch number (or lot number)" means a distinctive combination of numbers and or letters which specifically identifies a batch on the labels, the batch records, the certificates of analysis, and that permit the production history of the batch to be traced and revived. (7) The Central Licensing Board may authorise the Chairman to any of its members to perform any specific function of the Board for a specified period. Captcha: 9 + 4 = Sign In. 4.9.5 Avoiding direct contact with materials Maintenance of clean area 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. 21. Form-5 (Click to Download) 2) Fill an affidavit on Rs. Sexual importance. (c) Recommended storage conditions and expiration date to be assigned to the specific formulation and package.. (3-B) Any application under sub-rule (1) or sub-rule (3) shall be accompanied by the proper fee specified in Schedule F. 6. 4.8.1 Written programme (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. Conditions of licence to manufacture drugs for experimental proposes: A licence issuing under rule 21 shall be subject to the following conditions, namely :-- Procedure to Follow When Applying for a License to Sell Drugs 1) Complete the form-5 that is mandated in the Drug Rules. (1) Sifter. Sanitation and hygiene 7,500 Substances Parenteral preparation in general: 22-04 to avoid a healthcare workforce shortage emergency. 1 2 3 is/are hereby licensed to manufacture by way of Basic Manufacture/Semi Basic manufacture/Formulation/Repacking at the following premises:- Methyl Salicylate. (2) The import, manufacture and sale of drugs shall be in accordance with the information contained in the applications in respect of those drugs or in any supplementary information or, where such information was amended by the Registration Board, in accordance with such amended information on the basis of which such drugs were registered: (iv) Names and qualifications of the Production Incharge and Quality Control Incharge for supervising manufacturing processes and Quality Control Department, and other technical staff working in these departments. Household remedies including-- (A) The following equipment is required for the manufacture of drugs for external appliances or suspense: (3) Filter press or other suitable filtering equipment such as metafilter or sparklet filter or Also-pad filter. 4.6 Duties of Production Incharges (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. A minimum of 1 hour of CE earned in the area of pharmacy law. Sodium Chloride. 4.6 Packaging Instructions 10.3.1 General Date of filling. The word "safe" shall not be used with respect to promotion unless properly qualified. 4. 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 Sterilization by dry heat APPLICATION FORM FOR RENEWAL OF REGISTRATION OF ALL KINDS OF DRUGS Name of the manufacturer/supplier. Sterilization by radiation (3) The licence for the manufacture of drugs for experimental purposes shall be in Form 4. In the case of operations involving floating particles of fine powder or dust, a suitable exhaust system should be provided. (7) A new drug, where new method of manufacture is contemplated or a change is proposed in source, standard or specification of the active ingredient or the finished product, may not require full investigations and clinical trials except in so far as they are necessary for the purpose of establishing bio-equivalence, absorption, acceptability or other such features. All arrangements for production and analysis must be in accordance with the registration and agreed by both parties. (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; Ichthammol. 18. SCHEDULE B-III 60. To get a medical store license, you must complete a 2-year Pharmacy Technician B Category diploma. 2. (g) the Drugs Controller, Ministry of Health, Government of Pakistan who shall be its ex-officio Secretary; [See rule 16 (bb)-7] 5. Venereal diseases. 12,500 Issuance of a drug-sales license or pharmacy license is a procedure given by the Pharmacy council of Pakistan (PCP). Name of the sample. (iv) licence to manufacture by way of repacking; and in case of proprietorship the names) of proprietors and their address (es), in the case of firm the name and names and addresses of its partners and in the case of company the name and address of the company and its directors). (d) Floors: Floors should be impermeable to liquids, smooth and free from cracks. Cough Preparations. Apply for a Pharmacy License / Pharmacy Pharmacy Pharmacy Exam Information Apply for a Pharmacy License Attention: If you are a military member or military spouse, please review our Military Resources page before applying. 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. (2) The Central Licensing Board shall, before cancelling or suspending a licence under sub-rule (1), provide an opportunity of being heard to the licensee. Signature of the examiner. 7.2 Prevention of cross-contamination and bacterial contamination in production 28. PARTICULARS TO BE RECORDED IN THE ANALYTICAL RECORDS 15 Type of container : Promotional material shall be factual and claims for cure, prevention or relieve of an ailment shall be made only if this can be substantiated. (8) Contraceptives. 10. Phone - (717) 783-7156. 21. CRF due C R F paid as per Col. 41 2 3 4 5 I/we.of .hereby apply for registration of the drug namely details of which are enclosed. (3) The Registration Board may appoint a sub-committee consisting of at least one Clinical Professor, one pharmacologist and one pharmacist to make a detailed examination of each case and to submit a report for the consideration of the Board. (b) The applicant shall provide adequate space, plant and equipment for the manufacturing operations; HTML PDF: 246-945-235: Nonresident pharmacy license. 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 :-- (ii) Tableting Section; 7.3.5 Yield deviations (ii) Batch number(s) 3.4 Self inspection (iv) hygienic garments shall be worn by all staff in processing and packaging areas; 5. Ephedrine Sulphate. 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 :-- HTML PDF: 246-945-245: Health care entity license. Requirement for Assistant Pharmacy License Holder of a recognized assistant pharmacist certificate FORM 5 (ii) medical inspection of workers at the time of employment and periodical check up thereafter at least once a year; (3} Granular 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, Date of issue .. Graduates Pharmacist Licensure by Endorsement for Non-U.S. Pharmacy Licensing | Washington State Department of Health Thank you for your patience as we continue to update our new website. 3. 6 wherever necessary. Name of the material 3.6.6 Follow-up action degree program in the United States requires at least 2-years of specific pre-professional (undergraduate) coursework followed by 4-academic years (or 3-calendar years) of professional study. 4.10 S.O.Ps Miscellaneous (i) adequate facilities for first aid; SCHEDULE D-I 54. For efficient operation, the tablet production department shall be divided into the following three distinct and separate sections situated in different rooms, contribute one per cent of his gross profit before deduction of income-tax towards the Central Research Fund to be maintained by the Federal Government and utilised by it in accordance with the Drugs (Research) Rules, 1978: (l-B) An application under sub-rule (l-A) shall be accompanied by the proper fee specified in Schedule F : and Bismuth Subnitrate. (ii) if the application for renewal is made within thirty days after the expiry of the period of validity of a certificate Personnel Nebraska Governor Pete Ricketts recently signed Executive Order No. Stability studies : The Doctor of Pharmacy (Pharm.D.) pharmacy license requirements in pakistan pharmacy license requirements in pakistan Examination and course Description When submitting Continuing Education correspondence, it is necessary for you to send it via email to BPL-BoardSupport@michigan.gov.. 4.6 Rejected Materials Description of the method of manufacture and quality control with details of the equipment. Sec. The invitation letter should accurately reflect the presentations and discussions to be held. 3.3 Areas Proposed C and F and maximum retail price (in case of imported drug) : (ii) Where the usual information on indications and dosage is provided, that advertisement material shall contain information on contra-indications, side effects and other necessary precautions as may be applicable. DRUG REGISTRATION FEE 2.2 Layout (2) Kettle, gas or electrically heated with suitable mixing arrangement. (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. Whether the drug is registered for local manufacture or import 10.4.9 Equipment logbooks (7) (b) the content of active ingredient(s) per dosage form or regimen; Pharmacy (In-State Only) License. Building Layout And Its Pre-Approval3. 6.5.2 Release 4.2 Design Researching legal requirements is an important step in learning how to open a pharmacy, and you want to ensure that you have everything properly set-up before opening your business. There are two dispensing licenses offered by the Board of Pharmacy as outlined in guidance document 110-29. 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. (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: [Omitted vide S.R.O. 4.2 The contract shall specify the way in which the authorized person releasing the batch for sale ensures that each batch has been manufactured in, and checked for, compliance with the requirements of the marketing authorization. 5. Calcium Lactate. SECTION-2 7.4.5 Printing operation checks 12. Name of the Firm. SECTION -- 3 (a) Description. Outside contractor 1. Tannic Acid. (g) precautions, contra-indications and warnings; The granulation, tableting and packing shall be done in this room. REQUIREMENTS OF PLANT AND EQUIPMENT Advertisements shall also indicate, where applicable, appropriate limitations to the use of the drug. 9. 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. (2) The licence shall be kept on the licenced premises and shall be produced at the request of any member of the Central Licensing Board or of Provincial Quality Control Board or an Inspector. 44. 4. (ae) "Ordinance" means the Drugs Ordinance, 1976 (IV of 1976); 9. ], reject the application for registration and inform the applicant of the reasons for such rejection in writing. 10. Proposed route of administration: Comparison of products shall be factual, fair and capable of substantiation. 8. Methylene Blue. 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. (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; (j) One Surgeon, to be nominated by the Federal Government. 6.11 Miscellaneous (3) An application under sub-rule (1) shall be accompanied by fee or-- 17. Alniminium Hydroxide Gel Dried. Sterilization by ethylene oxide Procedure Licensing Requirements. 8. Anyone who is not registered with the GPhC but practises as a pharmacist or pharmacy technician, or refers to themselves as such, is breaking the law and can be prosecuted. "Levels of cholinesterase activity should be interpreted by a doctor, but the following guide might be helpful :-- or at such other place(s) at the. All emergency and safety equipment must be frequently and regularly checked and maintained to ensure its conditions satisfactory. 3.3.6 Production record/batch review (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. (1) Tablet machine, single punch or rotary. (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 3. 8. Kaolin. Provided that in the circumstances beyond the control of a manufacturer,, of a drug which may lead to reduction in the production of that drug, the circumstances may be intimated to the Registration Board. Panamanian domestic regulations also require that the . washing, drying sterilisation of ampoules or vials prior to 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. 3.7.6 Recording and progress 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.