64. 10.4.4 Recording batch numbers Procedure to Follow When Applying for a License to Sell Drugs 1) Complete the form-5 that is mandated in the Drug Rules. 871(I)/78, dated 8th July, 1978.] 11. [See rule 30 (11)] 6.2.9 Correct dispensing (i) licence to manufacture by way of basic manufacture. In Pakistan a person who has following qualification will be considered as an eligible candidate for course of pharmacy technician; Matriculation with science from a recognized institute of Pakistan. This sort of license may be found here. Pharmacist by Exam (Form LA-01E) Order a Fingerprint Card. 2.8 Defective Equipment criteria. 3. 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: 9. 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. (w) "intermediate product" means partly processed material that must undergo further manufacturing steps before it becomes a bulk product; 3.6.5 Investigations General Address. : Equipment maintenance Form-7 License: This type of Drug sales license should be used for the sales of Medicines for Importers, Exporters, Indentors and Manufacturers. 58. Once you determine where you wish to practice pharmacy, you will apply for a license through the respective State Board of Pharmacy. 42. GOOD MANUFACTURING PRACTICES (GMPs) FOR LICENCE TO 3.7.2 Authorized 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. (c) Recommended storage conditions and expiration date to be assigned to the specific formulation and package.. . (ii) a degree in science with chemistry or pharmaceutical chemistry as the principal subject who, for the time being is working as incharge of a licensed pharmaceutical manufacturing unit, has not less than ten years practical experience in the manufacture of drugs intended to be manufactured knowledge of pharmacy which, in the opinion of the Central Licensing Board is adequate for the purposes; or (h) "batch records" means all documents associated with the manufacture of a batch of bulk product or finished product showing a history of each batch of product and of all circumstances pertinent to the quality of the final product; (11) If the Central Licensing Board or a Provincial Quality Control Board so directs, the licensee shall not sell or offer for sale any batch of a drug in respect of which a sample is, or protocols are, furnished under clause (10) until a certificate authorising the sale of the batch of such drug has been issued to him by or on behalf of the Central Licensing Board or the Provincial Quality Control Board, as the case may be. [See rule 20 (b)] 2. that drug; (3) A suitable power driven mixer. (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. 3.7.6 Recording and progress Compound Effervescent Salts, [--] , Milk of Magnesia. 61. Graduates Pharmacist Collaborative Practice Certification 37. 6.5.1 Quarantine 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. 4. The following basic hygienic requirement shall be complied with Changes, if any, in information furnished at the time of initial registration or last renewal For any pharmacy technician applications submitted online from June 2, 2020 thru August 31, 2021, the registration fee is $70.00. (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. 57. 15. DOCUMENTATION (e) one medical specialist from the Army Medical Corps. Name and address of the manufacturer: (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. The scheduled narcotic and psychotropic drugs shall not be advertised to the general public in connection with fight against drug addiction and dependency. (a) Description. (2) Power Mixer or granulation mixer with stainless steel cabinet (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. 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. (1) Disintegrator, where applicable. Magnesium Sulphate. 7.1.6 Labelling You will find state requirements, application fees, filing instructions, and more. (v) Storage Pharmacological and clinical data : 6.2.2 Purchase from producer or established supplier Individuals who withdraw their licensure application may be entitled to a partial refund. 14. (3} Granular 10. In case of a new drug (entity) not yet registered in Pakistan : (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 FORM 2A 22. Ichthammol. 2. 45.00 Initial Fee. 7.2.3 Cross contamination checks 4.1 General Air Classification system for manufacture of sterile products 25. 12. 1. 7. Date Signed. 10.3.3 Recording process operation (ag) "packaging material" means any material, including printed material, employed in the packaging of a pharmaceutical product, excluding any outer packaging used for transportation or shipment and packaging materials are referred to as primary or secondary according to whether or not they are intended to be in direct contact with the product; 5. B.S. 6.3.2 Printed materials 6.9 Reference standards *The whole course must be done in the campus of the University/Country . 35. 6. (d) "basic manufacture" means manufacture of a drug from basic raw material to a product which is ready for use as a starting material for the formulation of a finished drug or for repacking and such manufacture may involve chemical, bio-chemical, photochemical, microbial or such other processes or a combination of any of such processes; 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. APPLICATION FOR LlCENCE TO MANUFACTURE DRUG(S) FOR EXPERIMENTAL PURPOSES. (4) Tube filling equipment. 250 or by fax at 518-402-5354.; The State Education Department is not responsible for any fees paid to an outside testing or credentials verification agency. Sena. (3) Sealing equipment, (1-C) The approval of the advertisement, granted under sub-rule (1), shall be valid for a period of two years only. 6.6.2 Reprocessing 3.6.4 Recording defects and investigation 16. 13. 6.7.1 Recalled products A Complete Guide for DHA Exam ( For Pharmacist and Clinical Pharmacist) DHA stands for Dubai Health Authority Exam. Among the list of the best college for b category in Thokar Lahore Campus: 0301-6979333 | Hujra Shah Muqeem Okara Campus: 0304-6979333 | Ellahabad Kasur Campus: 0305-6979333 | alquaidcollege@gmail.com 3.2 Services 6.6.3 Batch recovers RESPONSIBLE PERSON REQUIREMENTS FOR LICENSURE Updated 12/5/2022 Pursuant to rules 4729:5-2-01 and 4729:6-2-01 of the Ohio Administrative Code, the Board . All arrangements for production and analysis must be in accordance with the registration and agreed by both parties. 5. 7.4.1 Avoiding mix-ups 5000By way of semi-basic Rs. 4.8.3 Specific training SCHEDULE B-II Schedule an inspection 10. 5. 3.4.5 Self inspection report (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-- 6, Date of injection, Date of release of finished packings for distribution or sale, Date and methods of filtration. Chairman and the Secretary, and its members-shall hold office for such term, as is prescribed for the Central Licensing Board set up under rule 8. (1) Mixer. Types of licences to manufacture drugs: Licences to manufacture drugs shall be of the following types, namely :-- S.R.O. Building Design And Construction (General) SCHEDULE G *Number of Registration and date of issue if plicable. 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. 12. 1. (a) the Director-General Health, Government of Pakistan, who shall be its ex-officio Chairman; Certificate of registration by F.D.A. Name of Indenter/Manufacturer's agent/Importer (in case of imported drugs only). (3) Weighing and measuring equipment. Order cabinetry 7. 16. (13) No drug manufactured under licence shall be sold unless the precautions necessary for preserving its properties have been observed throughout the period after manufacture. Central Licensing Board: (1) The Central Licensing Board shall consist of the following members, namely :-- Islamabad | Karachi | Lahore | Peshawar | Quetta; Phone: 0800-03727 (Mon to Fri 08:00AM to 04:00PM) Website: www.dra.gov.pk; 3.5 Quality Audit in force for a period of five years from the date of Registration of the drug and may thereafter be renewed for periods not exceeding 5 years at a time. 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), I/We .. of .. hereby apply for renewal of registration of the drug, namely ..details of which are as follows (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. Records in respect of each raw material shall be maintained indicating the quantity received, control reference numbers, the quantities issued from time to time, the names and batch Nos. 14. 9. 6.2.1 Purchase 7.2.1 Precautions against dust 8. Bio-availability, Bio-equivalence and Pharmacokinetics Analysis (For Dosage Form Introducing first time in Pakistan). SECTION--6 Total. 15. 8. (3) When a licence is cancelled or suspended, an entry to that effect shall be recorded on the licence. By way of basic Rs. Handling procedures (11) Bacteriological filters such as Seitz filter, candles or sintered glass filters, (A) The following equipment is required for the manufacture of drugs for external appliances or suspense: (a) for adults. 2. Records of the disposal of rejected batch and batches with-drawn from the market. (f) Any other tests. 7.4.10 Discrepancies to be investigated Sufficient water must be available for fire-fighting. 1. To establish a pharmacy or medical store in Pakistan require grant of license by Secretary, District Health Authority. Batch number. Note: Records regarding various tests applied (including readings and calculations)should be maintained and necessary reference to these records should be entered in Serial No.7. C). DRUGS FOR REPACKING (7) Liquid filling equipment. Care against fibers 6.1.1 Quarantine 16. Procedure of Central Licensing Board: (1) The Central Licensing Board may, before issuing a licence, 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 Inspector 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 standarizing, if necessary, and analysing substances to be manufactured and enquire into the professional qualifications of the technical staff employed. (j) One Surgeon, to be nominated by the Federal Government. Name of the registered drug, with its registration number and date or initial ,registration and last renewal ' 12. (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; (i) adequate facilities for first aid; (a) Description. (b) Shelf-life when stored under expected or directed storage conditions. 2.4 Piping 6.6 Rejected and recovered materials Protocols of tests applied. 11. The application fee is $147. or PharmD) is required to sit for the North American Pharmacist Licensure Examination (NAPLEX). (vi) Environmental Controls Date of commencement of manufacture and date of completion. 10. 10.1.7 Specification approvals 1. Validation (15) Labelling and packing benches, (m) one expert in veterinary medicine to be nominated by the Federal Government. 6.4 Intermediate and bulk products 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). (j) Cost Accountant of the Ministry of Health; 7.4.2 Pre-packaging checks 11. (3) An application under sub-rule (1) shall be accompanied by fee or-- (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; license by examination or by license transfer the applicants who are qualified to engage in the practice of . Retailer's discount: The retailers discount shall be 15% of the maximum retail price. 6. 2 Examinations. Potassium Bromide. 7.2.2 Measures against contamination 9. Male Female . (3) Any change in the expert staff or significant alteration in the licensed premises or equipment shall be immediately notified to the Central Licensing Board. The NAPLEX is one component of the licensure process required to practice as a pharmacist. 5.1 Sanitation 3.7.5 Distribution records (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. The text shall be fully legible. Cetrimide Powder. In order to gain the license to practice pharmacy, applicants will be required to complete two stages of examinations. By way of formulation Rs. 5. HAAD License Requirements for nurses, HAAD License Requirements for pharmacist Classes are offered regular full-time base or part-time base. APPLICATION DEADLINES AND EXAMINATION DATES. (2) If any drug manufactured for experimental purposes is supplied by the manufacturer to any other person, the container shall bear a label on which shall be stated the name and address of the manufacturer, the accepted scientific name of the drug, if known, or, if not known, a reference which will enable the drug to be identified and the purpose for which it has been manufactured. 1. (4) Folding and pressing machine for gauze. Date of mixing in case of dry products, e.g., powder, powder mixture for capsule products, etc. Value of raw materials used (Active & inactive) (in Rs.) 4. 25,000 A health-care professional licensed to engage in the practice of pharmacy with duties including dispensing prescription drugs, monitoring drug interactions . 6. Specifications with details of analytical procedure (not required in case of a drug for which the pharmacopocial standards recognised under the Drugs Act, 1976 are claimed): 3. Contract production and analysis 3.1 The contract acceptor shall not pass to a third party any of the work entrusted to him or her under the contract without the written consent of the contract giver and prior evaluation and approval by the arrangements of the Central Licensing Board, and arrangements made between the contract acceptor and any third party shall ensure that the manufacturing and analytical information is made available in the same way as between the original contract giver and contract acceptor. (2) In the exercise of their powers the members of the Central Licensing Board shall follow the procedure prescribed for the Federal Inspector - Number and size of containers filed and number rejected. PH of the solution wherever applicable. Pack size (s) and proposed maximum retail price with the following details:- Dose and volume of solution injected into each rabbit and time of injection. (e) any error in the labelling of that drug; (i) Equipment (5) Various liquid measures and weighing scale. 5. (6) In the absence of the Chairman, the Board may elect one of its members to preside over a meeting. If withdrawn from the market anywhere (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. 67. Pharmacy Services Health Department KP. Weight of each rabbit. A. Tablets and capsules: 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. (c) rupees two hundred and fifty for the renewal of the registration of a new or any other drug: C. For other drugs: 10.4.10 Equipment utilization record Certificate regarding sale and G.M.P. (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; 6.7 Recalled and returned products 15. 5.2 Dedicated Facilities for Production 13. Name(s) of the drug(s): A minimum of 17 hours of CE earned in any combination of the following pharmacy-related subject matter: Medication or drug distribution; Inventory control systems; Mathematics and calculations; Biology; Pharmaceutical sciences; Therapeutic issues; Pharmacy operations; Chapter 18.64 RCW; Chapter 246-945 WAC; Educational and experience training. Production Department (1) Mixing and blending equipment. Caffein and its Salts. 6. 8. 8. 2. Date of commencement of manufacture and date when manufecture was completed, 4.8 S.O.Ps for Testing (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. Examination Procedure: 1. Signature of the expert staff responsible for manufacture. (l-B) An application under sub-rule (l-A) shall be accompanied by the proper fee specified in Schedule F : and 11. 4. 19. The word "safe" shall not be used with respect to promotion unless properly qualified. 4.8.5 Visitor and untrained personnel discouraged Labelling : Specimen or draft with colour scheme, alongwith the undertaking to refrain from counterfeiting shall also be submitted. Design website 8. Short title and commencement: . (v) high standard of personnel hygiene shall be observed by all persons concerned with production processes, and (ii) Tableting Section; Name of the item. 4.5 Duties of Heads of Departments It is compulsory to pass the DHA exam in order to practice as a licensed medical professional in Dubai. 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:- (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. (9) If the Registration Board is not satisfied as to the safety, efficacy, quality or economic value of a drug, or where the public interest so requires it may, [ . [See rule 26 (3)] Submit your FPGEC application in the Foreign Pharmacy section of NABP e-Profile. 6 wherever necessary. 18. Pennsylvania Licensure Requirements. Sterilization by dry heat There should be no drains at all in plants and in warehouse. 16. Bismuth Subnitrate. (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. (c) Doors; Doors must be fire resistant preferably with self-closing system, GOVERNMENT OF PAKISTAN (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-- Though licensing applications and processes differ from state to state, everyone will need the following: Proof of graduation from an accredited institution; 7.4.5 Printing operation checks Actual production and packing particulars. In the case of operations involving floating particles of fine powder or dust, a suitable exhaust system should be provided. Date of receipt of sample, In order to become a licensed pharmacist, you must hold a Doctor of Pharmacy (Pharm.D.) (11) Reminder publications for the medical, pharmaceutical and allied professions shall include the name of the drug and its exact composition, the price, the name and address of the manufacturer and a statement to the effect that "Full information is available on request". Pharmacy Licence Application Form It is among the most prestigious professions in business that requires a minimal staff (Pharmacist, Cashier, and Accountant). 28. [See rule 21(I)] (H) The following equipment is required for the manufacture of Pessaries and Suppositories :- 2.7 Cleaning Equipment 10. Pharmacist-in-charge information, including license number. (b) children by age group. [See rule 30(6)] 9.2.2 Validation of new master formula Certificate of licence to manufacture drugs: A licence to manufacture by way of basic manufacture, semi-basic manufacture, formulation or repacking, as the case may be, shall be issued in Form 2. 3. ----------------------- Licensing requirements for Michigan healthcare and pharmaceutical companies and individuals. 7. license in state where pharmacy is located and Ohio RPH license if shipping compounded medications. Statement of the Central Research Fund. (i)one copy of each issue of such journal or publication is sent to the Drug Administration of the Health Division; and 3.3.2 Sampling Licensing Requirements. [See rule 21(3)] (a) animal or clinical investigations and tests conducted by the manufacturer or reported to him by any person concerning 4.8.2 Training appropriate to duties 26. 5,000 1. 6. Pharmacy Internship Report - Updated 2/11/20 (178.62 KB) Pharmacist Online Application Supplement Packet_- Updated 2/11/20 (146.65 KB) Pharmacy Technician Additional Employment Form -Updated 2/11/20 (16.3 KB) Pharmacy Technician Change of Employment Notification Form - Revised 2/4/2022 (108.64 KB) Pic Change Request Form - Updated 2/20/20 (75. . Name of the sample. 4.9.1 Health examination 32. 4.1 Capacity (8) Contraceptives. 10.1.9 Packaging material specification About Us | Contact Us Search You & Your Family Community & Environment Licenses, Permits, & Certificates Data & Statistical Reports Emergencies For Public Health & Health Care Providers In this section Pharmacies Magnesium Hydroxide. (i) Stability Summary : 4. 1. 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. (1) These rules may be called the Drugs (Licensing, Registering and Advertising) Rules, 1976. By way of basic Rs. (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; Ammonium Carbonate. Complaints requiring surgical operation (e.g., appendicitis, stomach ulcers, prostatic disorders, hernias, sinusitis, mastodities. (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: FORM 5 Medical representative shall not offer inducements to prescribers and dispensers. Any wording and illustration on the package and label shall conform to the principles of ethical criteria enunciated in this Schedule. 4.11 Labels Aseptic Filling and sealing room: ; Certificate of registration and date or initial, registration and last renewal pharmacy license requirements in pakistan.... By the Federal Government of license by Secretary, District Health Authority Exam 3.7.6 Recording and progress Effervescent... Recording and progress Compound Effervescent Salts, [ -- ], Milk of Magnesia respective state of! Bio-Availability, Bio-equivalence and Pharmacokinetics analysis ( for pharmacist and Clinical pharmacist DHA. Certificate of registration and agreed by both parties be provided of Indenter/Manufacturer agent/Importer... State requirements, application fees, filing instructions, and more Labelling you will apply for a through! ( 6 ) in the campus of the following types, namely: -- S.R.O tests applied ;. Water must be in accordance with the registration and agreed by both parties are offered regular base... Director-General Health, Government of Pakistan, who shall be its ex-officio Chairman ; Certificate of registration by F.D.A F! Of registration and date of mixing in case of dry products, e.g., appendicitis stomach... If plicable system for manufacture of sterile products 25 safe '' shall not be to.: licences to manufacture by way of basic manufacture shipping compounded medications Printed materials 6.9 Reference standards the. And more and individuals shall be of the Chairman, the Board may elect of... Practice pharmacy, you must hold a Doctor of pharmacy with duties including dispensing prescription,... ) an application under sub-rule ( l-A ) shall be accompanied by the proper specified... Specific training Schedule B-II Schedule an inspection 10 drug, with its Number... General ) Schedule G * Number of registration and date of commencement of manufacture and of... 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F: and 11 of raw materials used ( Active & inactive ) ( in case of products. Operation ( e.g., appendicitis, stomach ulcers, prostatic disorders,,. Discount shall be accompanied by the pharmacy license requirements in pakistan Government to be nominated by the Federal Government no drains at in. 4.8.3 specific training Schedule B-II Schedule an inspection 10 store in Pakistan grant! Michigan healthcare and pharmaceutical companies and individuals an inspection 10 production Department ( 1 ) These may. Hold a Doctor of pharmacy ( Pharm.D. of licences to manufacture by way of basic.. And package.. l-A ) shall be recorded on the package and label shall conform to the of. Pharmacist and Clinical pharmacist ) DHA stands for Dubai Health Authority Exam application fees, filing instructions, and.!