Changes, if any, in information furnished at the time of initial registration or last renewal Main Pharmacological group to which the drug belongs: (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. DETAILS OF THE FIRM (4) Water still or Deioniser. There should be no drains at all in plants and in warehouse. 1. Batch Size, (g) Toxicity test, wherever applicable. WHICH IS PROHIBITED (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: SECTION -- 3 17. 5. 4.9.3 Illness (9) No act or proceeding of the Central Licensing Board shall be invalid merely on the ground of the existence of any vacancy in, or any defect in the constitution of the Board. 14. Conditions for grant or renewal of a licence to manufacture drugs by way of basic or semi-basic manufacture: (1) Before a licence to manufacture by way of basic or semi-basic manufacture is granted or rehewed, the Central Licensing Board shall satisfy itself that the following conditions are complied with by the applicant, namely :-- 5 whenever necessary. 7.4.11 Destruction of un-used packaging materials 3.6.2 Person authorized Analytical report number. Stability Summary : (5) Pessary and tablet counter. (c) experiences, investigations, studies and tests involving the chemical or physical properties or any other properties of that drug; FORM 7 (a) Description. One must pass this exam to be registered as pharmacist. Sterilization by heat 1.6 In the case of contract analysis, the final approval for release must be given by the authorised person(s). The contract 4.1 A contract shall be drawn up between the contract giver and contract acceptor that specifies their respective responsibilities relating to the manufacture and control of the product, and technical aspects of the contract shall be drawn up by competent persons suitably knowledgeable in pharmaceutical technology, analysis, and good manufacturing practices. HTML PDF: 246-945-246: Wholesaler. 1. 3.2 Laboratories 5. (12} Filling and. (h) Any other teats. 16. Prescription drugs should only be purchased from wholesale drug distributors licensed in the United States. HAAD License Requirements for nurses, HAAD License Requirements for pharmacist Classes are offered regular full-time base or part-time base. _________________________ C). SCHEDULE D-I 10.1.7 Specification approvals Pharmacist by Exam (Form LA-01E) Order a Fingerprint Card. The wording of the pcakge inserts or leaflets, if prepared specially for patients, shall be in lay language subject to the condition that the medical and scientific content is properly reflected. Quantity received. Application fee for Advertisement. (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; (C) The licensee shall comply with such further requirements, if any, as may be specified under any rule subsequently made. (2) Coating pan. GOOD PRACTICES IN MANUFACTURING PROCESSING (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. [See rule 7] GOVERNMENT OF PAKISTAN 6.9.1 Testing prepared reference standard Conditions of licence to manufacture, by way of basic manufacture, semi-basic manufacture formulation and repacking of drugs: (1) A licence to manufacture by way of basic, semi-basic manufacture, formulation or repacking of drugs shall be subject to the conditions stated herein, if any, and to the further condition that the licensee shall continue to maintain conditions on the basis of which he was granted a licence. (5) Mixing and storage tanks of stainless steel or of other suitable material. (a) adequate space and equipment shall be provided; wherever necessary QUALITY CONTROL DEPARTMENT (A) For the grant of Registration Rs. (bb) An applicant for registration of insecticides, pesticides and household disinfectants shall, in addition to the conditions specified in Schedule B and Schedule B-l, comply with the conditions specified in Schedule B-l, A. 3.7 Product recalls 4. B. Parenteral preparation: Cetrimide Powder. 4.3 Bays In package inserts or leaflets the manufacturers or distributors shall ensure that the information reflected is correct. 2. Japan, USA and European Company Member countries. Comparison of products shall be factual, fair and capable of substantiation. (8) Advertisement of a drug or any substance referred to in clause (ii) of Section 24 shall include such information or any risks and other precautions as may be necessary for the protection of public health, and in the case of drug also its maximum retail price fixed under Section 12. (See rules 19 and 30) 3.6.3 Written procedures Design website 8. (14) Leak tasting equipment. D. Raw materials: Number and size of containers filed and number rejected. Advertisements shall also indicate, where applicable, appropriate limitations to the use of the drug. Note: Sterile filling would not normally be regarded as part of packaging, the bulk product being the filled, but not the finally packaged, primary container. No. DOCUMENTATION (ap) "recovery or blending" means the introduction of all or part of previous batches, or of redistilled solvents and similar products, of the required quality into another batch at a defined stage of manufacture; 14. 8. The Doctor of Pharmacy degree (often abbreviated Pharm.D. Date of Registration Secretary Registration Board (Seal) Chairman. Form-7 License: This type of Drug sales license should be used for the sales of Medicines for Importers, Exporters, Indentors and Manufacturers. (2) Stainless steel scoops end vessels. (ii) The licence authorises the sale by way of wholesale dealing and storage for sale by the licensee of the products manufactured under this licence, subject to the conditions applicable to licences for sale. Potassium Citras, Glycerin, Paraffin, Oxygen gas, Disinfectant fluids, mechanical contraceptives, surgical cotton and tinctures which are not listed in this Schedule. 35. Particulars regarding the precautions taken during manufacture to ensure that aseptic conditions are maintained. Validation The following equipment is required in each of the three sections :- [See rule 17(1)] (6) Hot air drying ovens. Recording sterilization cycle Pharmacy Technician Registration Requirements & Application (online application) (2) Trimming machine. Sodium Thiosulphate. 15, Reference to Analytical Report numbers stating whether of standard quality or otherwise. 7. (i) Results of assay. Name(s) of the drug(s): pharmacist registration renewal process in india. Any individual, LLP, partnership firm, OPC or company can apply for a drug license. Warranty under Section 23(I)(i) of the Drugs Act, 1976 FIHS is registered with Pharmacy Council of Pakistan and Punjab Pharmacy Council to offer Pharmacy Technician (Category-B) professional diploma. 5 wherever necessary. (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. Sulphur Precipitated. (e) Disintegration test (time in minutes). The granulation, tableting and packing shall be done in this room. 2.1 Manufacturing operations They shall be adequately trained so as to posses sufficient medical and technical knowledge and integrity to present information on products and carry out other promotional activities in an accurate and responsible manner. 30. (a) the Director-General Health, Government of Pakistan, who shall be its ex-officio Chairman; Date of release finished packings for distribution or sale. (i) Layout 33. Pharmacy Services Health Department KP. Composition of the drug stating quantity of each active and non-active ingredients per unit dose or percentage of total formulation: (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. 56. Duration of certificate of registration: A certificate of registration under this chapter, shall, unless earlier suspended or cancelled, be. The Tableting Section shall be free from dust and floating particles. All Pharmacy Technicians licensed after January 1, 2008 must become CERTIFIED or STUDENT either when the license is issued or on or before the second license renewal. The more commonly issued license is the "practitioners of the healing . (e) dosage form or regimen; Verification can be emailed Chloral Hydrate. (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. * This product has been authorised to be place of the market for use in this country. HTML PDF: 246-945-235: Nonresident pharmacy license. Procaine Hydro-Chloride. SCHEDULE B-III 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. 1.Analytical report number (5) No application shall be entertained within three months of the rejection of an application under sub-rule (4). 3. Bacteriophages. The word "safe" shall not be used with respect to promotion unless properly qualified. (1) These rules may be called the Drugs (Licensing, Registering and Advertising) Rules, 1976. (h) one representative, not below the status of an officer of BPS- 19 [..], of each of the Ministries of Commerce Industries & Justice to be nominated by the Federal Government; and 31. 9.2 Process validation The premises and plan will be ready for inspectionon or are ready for inspection. 3.3.4 Test requirement for in-process controls (iv) Validation Gentian Violet. (c) major precautions, contra-indications and warnings, if any; and (au) "Schedule" means Schedule to these rules; (a) recommended clinical use and the claims to be made for the drug. Sena. Captcha: 9 + 4 = Sign In. CRF due C R F paid as per Col. 41 2 3 4 5 (5) A separate room shall be provided .for sterilisation, testing (for leaks and floating particles) and dryin 3. 10.4.1 General 2.3 The contract giver shall ensure that all processed products and materials delivered by the contract acceptor to comply with their specifications or that the product has been released by the authorised person(s). Provided that the Federal Government may, if in its opinion the public interest so required, withdraw the approval granted to any advertisement or modify or alter any condition subject to which the advertisement was approved. (ax) "standard operating procedure" means an authorized written procedure indicating instructions for performing operations not necessarily specific to a given product or material but of a more general nature such as equipment operation, maintenance and cleaning validation, cleaning of premises and environmental control sampling and inspection, and certain standard operating procedures may be used to supplement product specific master and batch production documentation; at least one person holding a degree in pharmacy, medicine, science with chemistry or chemical engineering from a university in Pakistan or any other institution, recognised by the Federal Government for the purposes of the Ordinance, and shall possess qualifications and experience which, in the opinion of the Central Licensing Board, is appropriate and adequate for the manufacture and handling of the drug to be, or being, manufactured. Application for registration of drugs and fees thereof: (1) An application for registration of a drug shall be made in Form 5 or 5-A in duplicate to the Registration Board addressed to its Secretary, and separate application shall be made for each drug. Number of mice used and weight of each mouse, Strength and volume of the drug injected, (s) "formulation" means all operations involved in converting a drug into a final pharmaceutical dosage form ready for use as a finished drug including compounding, processing, formulating, filling, packing, finishing, labelling and other like processes; (i) The licence will be in force for a period of five years from the date of issue unless earlier suspended or cancelled. (13-A) The licensee or his authorised agent shall issue a warranty in Form 2-A For any drug sold by him for the purpose of re-sale or distribution. Ammonium Carbonate. (ad) "new drug" means a drug that has not been commonly sold or distributed to the public in Pakistan and is introduced for the first time; 7. 6. Dated Signed Fish Liver Oil and its equivalents. 3.5.1 Audit by independent specialist Workers should not be exposed again to cholinesterase inhibiting compounds until further tests show a blood cholinesterase activity within 20% of the pre-exposure value. license by examination or by license transfer the applicants who are qualified to engage in the practice of . Develop a plan 4. Pharmacy Miscellaneous Permit (Out-Of-State Pharmacies) License. The scheduled narcotic and psychotropic drugs shall not be advertised to the general public in connection with fight against drug addiction and dependency. Order cabinetry 7. Apply for insurance 11. II. 17. Air supply system 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. (ba) "validation" means the documented act of proving that any procedure, process, equipment, material, activity or system works correctly and actually leads to the expected result; and 4. (1) Jacketed kettle, or equivalent steam, gas or dect1cally heated for preparing solution. 1.2 General.-- Contract production and analysis shall be correctly defined, agreed and controlled in order to avoid misunderstandings that could result in a drug or work or analysis of unsatisfactory quality. Rs. 6. 10.3 Batch processing records (7) In case an application for licence to manufacture is made after the expiry of six months from the date of rejection of an application under sub-rule (1), such application shall be treated as a fresh application and full fee shall have to be deposited. 7.1.2 Material handling 32. Potassium Acetate. Contract Manufacture.-- Manufacture or analysis on contract is permissible on behalf of a licensee or of a pharmaceutical company whose products are registered in Pakistan for sale subject to the conditions laid down in Schedule G," as a special case and for genuine reasons as approved by the Registration Board. If you want to do your own job as a pharmacist in the state of Maharashtra, then you . 17, Actual production and packing particulars indicating the size and quantity of finished packings, (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; 3.4.1 General (iv) adequate precautions for safe-guarding the health of the workers, including measures to avoid industrial accidents or diseases. Benzoic Acid. (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; 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. State Board of Pharmacy. 3.7.2 Authorized procedures (2) Pill machine, where applicable. (f) one pharmaceutical chemist or expert in quality control, to be nominated by the Federal Government; Signature of the Analyst, 4.9.5 Avoiding direct contact with materials Coating Section: Ensure contact between gas and microbial cells (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. (C) Equipment for the manufacture of Pills and Compressed Tablets including Hypodermic Tablets. 3.2 Basic requirements (i) adequate facilities for first aid; Introduction . Advertisement shall not generally be permitted for prescription drugs or to promote drugs for certain serious conditions that can be treated only by qualified health practitioners. 57. This licence shall, in addition to the conditions specified in the rules made under the Drugs Ordinance/Act, 1976, be subject to the following conditions namely:- 25. and Denmark. (g) Results of assay. (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; 9.2.2 Validation of new master formula FORM 4 6.5.2 Release Pay your fees using internationally accredited credit cards e.g. Signed WV Board of Pharmacy 1207 Quarrier Street, 4th Floor Charleston, WV 25301 Phone: 304-558-0558 Fax: 304-558-0572 Email: Contact Form | [email protected] 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. Use of disinfectants and detergents [See rule 30 (11)] HTML PDF: . 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. 7.2.1 Precautions against dust Date of commencement of manufacture and date when manufecture was completed, Choose a License Type or Permit Pharmacist Licensure by Examination For U.S. and Puerto Rico Graduates Pharmacist Licensure by Endorsement for U.S. Any wording and illustration on the package and label shall conform to the principles of ethical criteria enunciated in this Schedule. Pharmacological group _________________________ 8. and dispensing of drugs established under (b)(7) of this section must be consistent with the requirements of secs. (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. GENERAL CONDITIONS Advertisements in any form to the general public.- (1) Advertisements to the general public, where permissible, shall help people to make rational decisions on the use of drugs determined to be legally available without a prescription. 7. The License can be renewed as it is valid for up to five years. ------------------------ 10. 45.00 Initial Fee. 10. (1-A) An application for advertisement of any drug, substance, remedy, treatment or offer of treatment for any disease shall be made it Form-8, addressed to the Secretary of the Commissioner on Advertising and there shall be made a separate application for each advertisement. Quality control 3.3.2 Sampling (e) Testing, 21. Panamanian domestic regulations also require that the . By way of basic Rs. (6) A licensee who for any purpose is engaged in the culture or manipulation of pathogenic spore bearing micro-organisms shall provide, to the satisfaction of the Central Licensing Board, separate laboratories, utensils and apparatus required for the culture or manipulation of such .micro-organisms, and they shall not be used for the manufacture of any other substance. 5,000 (c) the generic name(s) of other ingredient(s) known to cause problem(s) FORM 1-A Batch number. (2) Dosage form(s) of drugs. DISEASES, ADVERTISEMENT FOR TREATMENT OF 16, Records on the disposal of rejected batches and batches with-drawn from the market. Prescribers and dispenses shall not solicit such inducements. 4. 6.4.1 Storage 58. Sec. (c) infants. 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". SCHEDULE D Methylene Blue. To get a medical store license, you must complete a 2-year Pharmacy Technician B Category diploma. (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 :-- (5) Mixing tanks for processing medicated dressings. SCHEDULE G 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: Types of licences to manufacture drugs: Licences to manufacture drugs shall be of the following types, namely :-- 10.4.4 Recording batch numbers 10.4.3 Recording packaging operation 4. 42. (l) "clean area" means an area with defined environmental control of particulate and microbial contamination, constructed and used in such a way as to reduce and or eliminate introduction, generation and retention of contaminants within the area; (3) The filling and sealing rooms shall likewise be air-conditioned under positive pressure with air locks provided to. (D) The following equipment is required for the manufacture of Powders :-- (8) Hot Air Steriliser, 4.9.7 Foods and drinks prohibited Local exhaust system must be effective,. For efficient operation, the tablet production department shall be divided into the following three distinct and separate sections situated in different rooms, 11. 5. Disciplinary and criminal history for owners and officers of the pharmacy. (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. Aseptic Filling and sealing room: 9.2.1 Validation of critical processes 1362(I)/96-28.11.96). (a) For the grant of licence: 7.1.6 Labelling 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. 6.4 Intermediate and bulk products On the disposal of rejected batches and batches with-drawn from the market [ See rule 30 ( 11 ]. 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