Medical representative shall not offer inducements to prescribers and dispensers. Date Signed. (2). (ii) Dossage form(s) of drugs. Sterilization by heat (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. (f) the applicant shall ensure that-- Licensing Authority. 6.2.6 Labelling 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. C.). HTML PDF: 246-945-235: Nonresident pharmacy license. 7.4.2 Pre-packaging checks Pharmacists will have to arrange their own internship in either a hospital or community pharmacy setting. (1) Mixing tanks where applicable: (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. (i)one copy of each issue of such journal or publication is sent to the Drug Administration of the Health Division; and (i) Equipment 10.1.10 Starting material re-assay Signature of the Analyst. (iii) facilities for vaccination and inoculation against the enteric or any other epidemic group of diseases; and 19. Protective garments in grade B room * This product has been authorised to be place of the market for use in this country. Retailer's discount: The retailers discount shall be 15% of the maximum retail price. Patent number, if any, with date and its date of expiry : 16. 4.9 S.O.Ps for Sanitation ST-PHARMACY@PA.GOV. 7. 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. Its steps are mentioned as follows Firstly download and fill the prescribed form-5 in drug rules ( click this link to download ). (3} Granular 32. Sanitation and hygiene Language which brings about fear or distress shall not be used. Warranty under Section 23(I)(i) of the Drugs Act, 1976 DRUG REGISTRATION FEE This room shall be air-conditioned. 13. (10) No drug or any remedy, treatment or after treatment of any disease specified in Schedule 'E' shall be advertised except as provided in sub-rule (2). (1) Mixer. (d) The applicant shall establish an independent Quality Control Department and maintain separate staff, premises and adequate laboratory equipment for carrying out tests of strength, quality and purity of the substances being or to be used in the manufacture. (b) children by age group. (13) Inspection table with draft and light background 3.4.1 General 6.1 Rest Rooms 2. 1993. Sodium Metabisuphite. (ii) licence to manufacture by way of semi-basic manufacture; Date of filling. Maintenance of clean area (d) Extreme Temperature Fluctuations Study for all liquid and semi-solid preparations. 14. General HTML PDF: 246-945-233: Hospital pharmacy associated clinics. [See rule 16 (6) (b)] 8. Name of the drug, (iv) Services 1. (a) for adults. 3. Quality control. 6.2.5 Delivery from different batches Renewal of a licence: On application being made for renewal, the Central Licensing Board may cause an inspection to be made, and if satisfied that the conditions of the licence and the rules are and will continue to be observed, shall issue a certificate of renewal or otherwise reject the application and inform the licencee accordingly. To LOG IN or CREATE a DELPROS (Delaware Professional Regulation Online Services) user account: Go to: https://delpros.delaware.gov/OH_HomePage. 3.3.3 Test requirement for starting and packaging materials Building Design And Construction (General) Sterility testing (iii) Name of the drug(s) registered/approved. 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. Types of licences to manufacture drugs: Licences to manufacture drugs shall be of the following types, namely :-- 3.6.1 Review of complaints [See rule 5 (2)] This exam is held 4 times a year 2. 5. Care against fibers (3) An application under sub-rule (1) shall be accompanied by fee or-- 15. (a) adequate space and equipment shall be provided; (k) "calibration" means the set of operations that establish, under specified conditions, the relationship between values indicated by a instrument or measuring system for especially weighing, recording and controlling, or the values represented by a material measure and the corresponding known values of a reference standard and the limits for acceptance of the results of measuring; (i) the claims to be made for the drug; (c) Filling and sealing: This includes filling and sealing of ampoules or filling and capping of vials. Personnel ADDITIONAL CONDITIONS FOR MANUFACTURE OF STERILE PRODUCT 7.1.6 Labelling 6.2.4 Damaged container [See rule 31 (10)] 33. Individuals who withdraw their licensure application may be entitled to a partial refund. (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. 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. (i) Layout E. Container, packing material, etc. Serial Number, (3) Scientific data in the public domain shall be made available, on request, to prescribers and any other person entitled to receive it as appropriate to their requirements. 7.3.6 Product pipelines Signature of the expert staff responsible for the manufacture, (ii) Any other relevant information that may be required by the Board for consideration of this application. 3.5 Quality Audit (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: Rs. Date of Establishment. 3.7.2 Authorized procedures (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, [ . One must pass this exam to be registered as pharmacist. Filling and Sealing Room: 3.3.1 General 9. Activities in clean areas kept minimum Tableting Section: (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. I/We . of hereby apply for the renewal of a licence to manufacture by way of on premises situated at 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 (l-B) An application under sub-rule (l-A) shall be accompanied by the proper fee specified in Schedule F : and 8. Brights disease, cataract, glaucoma, epilepsy, [] lacomotive ataxia, multiple sclerosis, lupus, paralysis, blindness. ENCLOSURES OF THE APPLICATION FOR REGISTRATION OF A DRUG (iv) hygienic garments shall be worn by all staff in processing and packaging areas; A. Tablets and capsules: Validation 2. Sterilized non-sterilizer products differentiation 6 wherever necessary. 4.9.2 Practices in personal hygiene (5) The Chairman and the Secretary of the Registration Board shall, after the Board has approved the registration of a drug, sign the certificate of registration. FORM -5(A) 1. [See rule 16 (bb)-7] Cetrimide Powder. Solution of serum proteins intended for injunction. 22-04 to avoid a healthcare workforce shortage emergency. 6.2.10 Checking 4 5 6 7 1.3 All arrangements for contract manufacture and analysis, including any proposed changes in technical or other arrangements, shall be in accordance with the registration of the drug concerned. 4.3 GMP awareness 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. Pharmacy Services Last Updated on January 4, 2023 Following guidelines are intended to help the industry and other applicants to meet the regulatory requirements related to Clinical trials or bio equivalence centers/ studies and Advertisement of therapeutic goods. Bioburden to be minimal 2. (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. 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. 8. _________________________ (6) Sintered glass funnel, seitz filter or filter candle. 2,500 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: Sampling of drugs: Samples of drugs may be provided to the physicians or dentists or Pharmacists or Veterinarians or a medical institution in a reasonable quantity and in reduced packings marked with the words "Physicians Sample Not for Sale". (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; (j) "bulk product" means any product that has completed all processing stages up to, but not including, final packaging; wherever necessary Pharmacological group _________________________ 5.1 General Facilities 10.3 Batch processing records (4) The licensee shall maintain in the inspection book provided by the Central Licensing Board at the time of the issuance of the licence on which a member of the said Board or of a Provincial Quality Control Board or an Inspector shall record proceedings of each of his visits, his impressions and the defect or irregularities noticed, if any, by him and such inspection book shall be signed by him as well as the licensee or his authorised agent. 6.1.1 Quarantine (2) The Registration Board may refer any case for detailed .examination to the committee of experts on the Drugs Evaluation constituted under Section 10 of the Act. Use of protective garments 9. (6) A triple-roller mill or an ointment mill, where applicable. Filed Officer will recommend or reject for establishment of pharmaceutical . Name of all ingredients, quantities required for the batch size, quantities actually used. 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. washing, drying sterilisation of ampoules or vials prior to Hygiene and cleanliness (i) Particulars regarding the legal status of the applicant (i.e. Dosage form of the drug: 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. Alniminium Hydroxide Gel Dried. 14. General (b) Identification. Potassium Citras, Glycerin, Paraffin, Oxygen gas, Disinfectant fluids, mechanical contraceptives, surgical cotton and tinctures which are not listed in this Schedule. 10.4.1 General Labeling of drugs manufactured for experimental purposes: (l) Any d-rug manufactured for experimental purposes shall be kept in containers bearing labels indicating the purpose for which it has been manufactured. 10. 7. (i) the name and address of manufacturer or distributor; [--] _________________________ (ii) if the application for renewal is made within thirty days after the expiry of the period of validity of a certificate 7.4.5 Printing operation checks 18. (a) "active pharmaceutical ingredient" means a substance or compound that is intended to be used in the manufacture of a pharmaceutical product as a pharmacologically active compound (ingredient); (12} Filling and. 1. (11) Subject to rule 14, the Central Licensing Board may appoint a licensing authority or authorities for such purpose as it may deem fit. (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. 10.1.4 Status identification (2) Granulator. 10.4.7 Recording batch distribution Duration: 2 years, annual system, NTS based examination Eligibility: There are two dispensing licenses offered by the Board of Pharmacy as outlined in guidance document 110-29. 6. (a) if that drug at any time, for safety reasons is withdrawn or banned or certain restrictions are imposed in any of the said countries, then it shall be the responsibility of the manufacturer in Pakistan or as the case may be, the indentor, to immediately withdraw the drug from the market in Pakistan or, as the case may be to impose similar restriction and to inform the registration Board within fourteen days of such an information having come to his knowledge and having taken the necessary action. 7.2.3 Cross contamination checks Granulating Section: (1) Disintegrator, where applicable. Pulv Gentian. Sodium Chloride. (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. Board shall be deemed to be an additional category of drug for the purpose of this Schedule. 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 :-- 50. (5) A calloid mill or a suitable emulsifier or homogeniser, where applicable. (8) Jar or tube filling equipment, where applicable. MATERIALS (1) Disintegrator, where applicable. (b) Disintegration time as often as practicable. Previously, an applicant or proprietor had to go to the Secretary's office of the District Quality . Pharmacy Services Health Department KP. 3.3 Control procedures S.R.O. Chloral Hydrate. (3) Name of the drug(s). The text shall be fully legible. Form-7 License: This type of Drug sales license should be used for the sales of Medicines for Importers, Exporters, Indentors and Manufacturers. 9. On trade price On retail price Indicate whether supplied through normal distribution, channels or exported or supplied to any specific institution. [Omitted vide S.R.O. 20. FORM 3 (2) The Registration (2) The Registration Board may, before issuing a registration], 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 Inspectors 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 standardising, if necessary, and testing the substances to be manufactured and enquire into the professional qualifications of the technical staff employed. (5) A drug or any substance referred to in clause (ii) of Section 24, may be advertised to the medical, pharmaceutical and allied professions through a documentary film. Yes, the physician must obtain from the Board of Pharmacy a license to dispense. (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; to be nominated by the Federal Government. Requirement for Pharmacist License Must hold a pharmacy certificate from a recognized high institute, college or university. (5) The meetings of the Central Licensing Board may be held at such time as the Board may deem fit and, on the request of any of its members, the Chairman may at any time call a meeting if there is any important matter for its consideration. Number of container packed In case of pessaries manufactured by granulation compression, if the licence does not have a tablet section, a separate area of minimum of 300 squared feet and the following equipment is necessary :-- [See rule 2 (e)] Name of Manufacturer. A. An area of maximum 300 square feet is required for the basic installations. (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). Fish Liver Oil and its equivalents. Pharmacy Services Health Department KP. II. Name of all ingredients, quantities required for the lot size, quantities actually used. 3.3 Areas Asepsis of articles in clean areas 17. Aspirin and Paracetamol in tablets and liquid forms. 3.3.7 Stability studies (ii) the route of administration; 3. Use of disinfectants and detergents Provided that an application for renewal shall not be entertained unless it has been made within sixty days after the expiry of the licence and when an application has been made as aforesaid the licence shall subject to the orders passed on the application for renewal continue in force for the next period of two years. 17. (C) The licensee shall comply with such further requirements, if any, as may be specified under any rule subsequently made. 6.4 Animal House (y) "manufacture" means all operations of production, quality control, release, storage and the related controls; (g) Toxicity test, wherever applicable. 7.3.5 Yield deviations PharmD Program Accreditation This professional degree program leading to the Doctor of Pharmacy degree is judged to meet established qualifications and education standards through initial and subsequent periodic evaluations. Sufficient water must be available for fire-fighting. Records of test to be carried out in case of tablets as under 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. 9.2 Process validation Equipment maintenance *The whole course must be done in the campus of the University/Country . Staff must not be allowed to go home wearing the same clothing they wore at work; emergency showers and eye washing facilities must be provided in the premises. Dated (Signed) (c) The licensee shall either in his own laboratory or, where so authorised under the proviso to clause (e) of rule 16, in any other laboratory approved by the Central Licensing Board, test each batch of the raw materials used by him for the manufacture of drugs and also each batch of the final drug, shall maintain records showing the particulars in respect of such tests as specified in Schedule B-III 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. 4.1 General (6) In the absence of the Chairman, the Board may elect one of its members to preside over a meeting. CONDITIONS FOR GRANT OF A LICENSE TO MANUFACTURE BY WAY OF FORMULATION Name, address and status of the applicant: (d) the approved therapeutic uses; For the procedure to withdraw your application, contact the Pharmacy Unit at opunit1@nysed.gov or by calling 518-474-3817 ext. 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. (b) the content of active ingredient(s) per dosage form or regimen; Bio-availability studies: prevent, the entry of air from outside. Description of bill of sale, invoice, bill of lading or other document (if any). (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; Male Female . 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