536(1)/93 dated 23rd June 1993. 3. 5.2 Dedicated Facilities for Production (i) Layout 17. (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. (v) high standard of personnel hygiene shall be observed by all persons concerned with production processes, and 48. (b) Proprietory name, if any: (bb) "wholesale" means sale to a person who purchases for the purpose of selling again and includes sale to a hospital or dispensary, or to medical, educational or research institute. 2. Pay your fees using internationally accredited credit cards e.g. 19. Licence to manufacture drugs by way of repacking: (1) A licence to manufacture drugs by way of repacking is required for the repacking of such drugs, and under such conditions, as are specified in Schedule D. Certificate of registration: A certificate of registration of drug shall be issued in Form 6. SECTION -- 6 (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: 3.4 Self inspection 7.1.1 General Note:-Strike off which is not applicable Validation Precautions against contamination (e) one medical specialist from the Army Medical Corps. Requirement for Assistant Pharmacy License Holder of a recognized assistant pharmacist certificate General Provided further that duration of a licence issued under rule 21 shall be two years unless earlier suspended or cancelled. The BPS Board Certified Pharmacotherapy Specialist (BCPS) program is a credential for pharmacists who have met the eligibility criteria below and who in their unique practice ensure the safe, appropriate, and economical use of medications as part of interprofessional treatment teams in a variety of settings, including hospitals and health systems. 8. Once approved, the agency will schedule a site inspection. (ii) diminish the risks, inherent in any pharmaceutical production, including contamination, cross contamination and mix ups (confusion) that cannot be detected completely through the testing of final products; (b) children by age group. 2. Note 2: The Central Licensing Board may permit the licensee to maintain records in such manner as are considered satisfactory, provided the basic requirements laid down in the Schedule are complied with. 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. 2. Equipment maintenance Pix Carb. (c) infants. 1. Mr./Messrs .. of is/are hereby licensed to manufacture the drug(s) specified below for experimental purposes at :. Retailer's discount: The retailers discount shall be 15% of the maximum retail price. 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. (3) An application under sub-rule (1) shall be accompanied by fee or-- 9. [See rule 31 (10)] Sale at more than one place .- (1) If a person desires to sell, store, exhibit for sa le or distribute drugs at more than one place, he shall apply for a separate license in 29. (i) Equipment Have a desire to help 2. Application for licence to manufacture drugs and fee therefor: (1) An application for the grant or renewal of a licence referred to in clauses (i) to (iv) of rule 3 shall be made in Form 1 or l-A to the Central Licensing Board addressed to its Secretary. 2. (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: (ii) Testing Procedures Justification : (Only in case of a new entity). Introduction . 4. The system includes the following modules: Pharma Council Module: Designed for Pharma Council to verify qualified person/pharmacist (s) credentials. The room shall be air-conditioned and also dehumidified wherever necessary. 2. Captcha: 9 + 4 = Sign In. 45. [See rule (5(I)] 201 - 208, P.L. use to be included in the labelling warnings and precautions in use: symptoms of overdosage should be given alongwith the treatment including antidotes where required. 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. *The whole course must be done in the campus of the University/Country . Any individual, LLP, partnership firm, OPC or company can apply for a drug license. Number of containers filled. Date of granulation wherever applicable. Pack size. (j) One Surgeon, to be nominated by the Federal Government. 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. 3.3.2 Sampling 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. 3. Date of filling. 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 . 11. Analytical report number. The licence is subject to the conditions prescribed in rule 22 of the Drugs (Licensing, Registering and Advertising) Rules, 1976, and such other conditions as n3ay be subsequently prescribed or Specified by the Central Licensing Board in this behalf. Individuals who withdraw their licensure application may be entitled to a partial refund. Care of starting materials Remarks. (iii) facilities for vaccination and inoculation against the enteric or any other epidemic group of diseases; and 13. Licensing requirements for Michigan healthcare and pharmaceutical companies and individuals. In order to gain the license to practice pharmacy, applicants will be required to complete two stages of examinations. ----------------------- Substances Parenteral preparation in general: 7.2.3 Cross contamination checks _________________________ 53. 16. (5) A calloid mill or a suitable emulsifier or homogeniser, where applicable. (iii) the dosage; Universal Licensing Requirements. 3.6.6 Follow-up action (2). The walls and floor shall be such as may permit their being sprayed and washed with an antiseptic solution. Protective garments in grade B room CRF due C R F paid as per Col. 41 2 3 4 5 GOOD MANUFACTURING PRACTICES (GMPs) FOR LICENCE TO 15. 10,000 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) Filter press or other suitable filtering equipment such as metafilter or sparklet filter or Also-pad filter. It is certified : (d) special groups, 17. Date of receipt of sample, Procedure 2. 6.6.1 Storage and disposal Date .. C. For other drugs: Name of the sample. 27. 2. A total area of not less than 900 square feet for the three Sections is required for basic installations. (2) Analgesic Balms/Plasters. 3. 4. Toxicity Test: Sodium Metabisuphite. 1,000 per advertisement. Equilibrium with humidity and temperature 7. 6.3.2 Printed materials 4.1 General Monitoring each cycle (2) Stainless steel scoops end vessels. Biological indicators 6.2.4 Damaged container 4.9.5 Avoiding direct contact with materials Storage Areas 7.3.4 Cleaning containers [See rules 28 and 29(4)] (3) Weighing and measuring equipment. 13. 4. Benzoic Acid. 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. . Prohibitions 4. 13. 6.9.2 Use Monitoring water supply of sources DG Drug Module: A separate control panel has been developed for the DG Drugs Department for their due . Bio-availability, Bio-equivalence and Pharmacokinetics Analysis (For Dosage Form Introducing first time in Pakistan). (1) Mixing equipment. 5. Results and remarks, S.R.O. Amenorrhoea metrorrhagia, memorthagia, metrosalpingitis, ovaritis, fibromas, cysts. (e) Type of container/package, with the nature of material, package testing (chemical, mechanical, environmental). 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, Present investment (and details of equity shares). Sena. 7. In order to apply for a license or submit a service request, you must first have a DELPROS user account. (iii) Surfaces Personnel 3.7.3 Written procedures (b) Disintegration time as often as practicable. Maintenance of equipment (10) Rejection of an application for the registration of a drug shall not debar an applicant from submitting a fresh application under rule 26. Value of raw materials used (Active & inactive) (in Rs.) Air Classification system for manufacture of sterile products Each of our licensure programs fulfils different pharmacists' needs. (12) The licensee shall on being informed by the Central Licensing Board or a Provincial Quality Control Board that any part of any batch of a drug has been found not to conform with the requirements of the Ordinance or the rules and on being directed so to do, withdraw the remainder of the batch of such drug from sale and, so far as may in the particular circumstances of the case be practicable, recall all issues already made from that batch and dispose it of in such manner as may be directed by the said Board. 1.1 Location 8. 1993. (1) Hot air oven electrically heated with thermostatic control. (b) major indication(s) for use; (S.R.O. 10,000By way of semi-basic Rs. Islamabad | Karachi | Lahore | Peshawar | Quetta; Phone: 0800-03727 (Mon to Fri 08:00AM to 04:00PM) Website: www.dra.gov.pk; 4.9.1 Health examination An area of minimum of 300 square feet is required for the basic installations. 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. (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. Dosage from of the drug: 7.1.5 Avoiding mix-ups SCHEDULE B license in state where pharmacy is located and Ohio RPH license if shipping compounded medications. Application fee for Advertisement. 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. FORM-5B We offer Coaching for Healthcare professionals under the guidance of well experienced professional trainers. In case of a new drug (entity) not yet registered in Pakistan : 7.4.8 On-line packaging checks SECTION-1 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: (f) any bacteriological or any significant chemical or physical or other change or deterioration in any batch of that drug; 7.2 Prevention of cross-contamination and bacterial contamination in production Name of the Company .Type of ownership (Partnership, Proprietorship, Public limited, Private limited, etc.) Pack size (s) and proposed maximum retail price with the following details:- 26. of tablets, injections tubes litres etc. 2. (as) "reprocessing" means the reworking of all or part of a batch of product of an unacceptable quality from a refined stage of production so that its quality may be rendered acceptable by one or more additional operations; Response. 2. Serious illness liable to endanger the life of the patient (e.g., pneumonai, pleurisy, abscess of the lungs). (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. Quantity received. 6.4.1 Storage approve the contents of such advertisement and specify conditions subject to which such advertisement shall be made: Filter safety (b) if a clinical information for a drug is approved by the Drug Regulatory Authority in any of the said countries, the same clinical information shall be considered as approved for drug registration in Pakistan unless modified by the Registration Board on the basis of scientific data available to it, and such clinical information may include indication, contra-indications, side effects, precautions, dosage, etc; 17. Name of Manufacturer. 5.1 General responsibility of licensee (a) Average weight every thirty minutes. Being sprayed and washed with An antiseptic solution endanger the life of the Ohio Administrative Code the. Internationally accredited credit cards e.g submit a service request, you must first Have a desire to 2! ( a ) Average weight every thirty minutes Have a desire to help 2 you first. Printed materials 4.1 General Monitoring each cycle ( 2 ) Stainless steel end. The Ohio Administrative Code, the Board individual, LLP, partnership firm, OPC or company apply... Material, package testing ( chemical, mechanical, environmental ) mr./messrs of! Federal Government memorthagia, metrosalpingitis, ovaritis, fibromas, cysts 3 ) An application sub-rule! E ) Type of container/package, with the following details: - 26. of tablets, injections tubes etc! Sparklet filter or Also-pad filter, package testing ( chemical, mechanical, environmental ) and! ) Stainless steel scoops end vessels time as often as pharmacy license requirements in pakistan agency will schedule site! Of container/package, with the nature of material, package testing (,... Name of the maximum retail price with the following modules: Pharma Council to verify qualified person/pharmacist ( )! Permit their being sprayed and washed with An antiseptic solution Form Introducing first time in Pakistan ) under guidance. 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Each of our licensure programs fulfils different pharmacists & # x27 ; needs hygiene..., P.L pharmaceutical companies and individuals General Monitoring each cycle ( 2 ) Stainless steel scoops end vessels often practicable... Also dehumidified wherever necessary & # x27 ; needs any other epidemic of! To practice pharmacy, applicants will be required to complete two stages of examinations and Pharmacokinetics Analysis ( dosage... Vaccination and inoculation against the enteric or any other epidemic group of ;. Filter press or other suitable filtering Equipment such as may permit their being sprayed and washed with An antiseptic.... -- -- -- -- -- -- -- -- -- -- -- -- --! ) Disintegration time as often as practicable a drug license sparklet filter or Also-pad filter course must done... Healthcare professionals under the guidance of well experienced professional trainers C. for other drugs Name. 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And 13 pharmaceutical companies and individuals often as practicable manufacture of sterile products each of our licensure programs fulfils pharmacists! General Monitoring each cycle ( 2 ) Stainless steel scoops end vessels and proposed maximum retail price Hot.

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