(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. This registration shall be valid for a period of five years unless earlier suspended or cancelled. (ii) the Federal Government may, after giving an opportunity of being heard, prohibit the publication of any advertisement in any such journal as it is found to violate any of the conditions specified under sub-rule (1). 7. 3.4 Surfaces [See rule 5 (/)] Form-5 (Click to Download) 2) Fill an affidavit on Rs. Coating Section: Care of starting materials A total area of not less than 900 square feet for the three Sections is required for basic installations. 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. If you want to do your own job as a pharmacist in the state of Maharashtra, then you . Name of the sample. Rs. STEP 4: Apply for PSV. [See rule 26 (1)] (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); 4.1 General 6. ---------------- (k) One physician, to be nominated by the Federal Government; Islamabad | Karachi | Lahore | Peshawar | Quetta; Phone: 0800-03727 (Mon to Fri 08:00AM to 04:00PM) Website: www.dra.gov.pk; (4) If the Central Licensing Board is not so satisfied, it shall reject the application and shall inform the applicant of the reasons for such rejection and of the conditions which must be satisfied before a licence may be issued. 9. FOR EXPERIMENTAL PURPOSES [See rule 26(3A)] (3) Punch and dyes storages cabinet. Benzoic Acid. 16. (1-C) The approval of the advertisement, granted under sub-rule (1), shall be valid for a period of two years only. 10.1.5 Product labelling [See rule 26 (3)] Sterility test as the last measures 2. (a) Building: Building should be provided with both good general ventilation and protection against direct sunlight, with easy access for fire-fighting equipment including fire-extinguishers, fire-blankets, .hose, reels and fire-alarm, etc. (b) Identification. (1) Hot air oven electrically heated with thermostatic control. _________________________ 19. Bismuth Subnitrate. Normal temperature of each rabbit. 29. Serial Number, 3. 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. (3) Employers shall be responsible for the statements and activities of their medical, representatives. 37. (d) any substitution of another substance for that drug or any mixing of another substance with that drug; (d) one pharmacist, to be nominated by the Federal Government; DG Drug Module: A separate control panel has been developed for the DG Drugs Department for their due . 6.9.3 Working standards Name of Indenter/Manufacturer's agent/Importer (in case of imported drugs only). 10. 4. Magnesium Trisilicate. 18. Name of the drug. (11) The manufacturer or as the case may be, the indentor shall follow the ethical criteria for medical drug promotion as given in Schedule G. (10) The Licensee shall, on demand, furnish to the Central Licensing Board or the Provincial Quality Control Board or to such authority as the Central Licensing Board may direct, from every batch of a drug, or from such batch or batches of drugs as it may from time to time specify, a sample for examination and, if required, furnish full Protocols of the tests which have been applied. Name of the sample. The Registration Board after getting the said intimation shall take similar action for the same drug available from other sources within the shortest possible time; (iii) the dosage; (vii) Packaging (3) The licence for the manufacture of drugs for experimental purposes shall be in Form 4. 7.3.8 Equipment calibration Personnel (14) The Licensee shall , by the 30th June and the 31st December each year, Whichever is immediately after the annual financial closing of the company. [See rule 26(I)] Sec. (a) the Director-General Health, Government of Pakistan, who shall be its ex-officio Chairman; Name of the Firm. Sodium Sulphate. [See rule 16 (bb)-7] (3) When a licence is cancelled or suspended, an entry to that effect shall be recorded on the licence. (d) Sterilisation. 3.7.7 Evaluation Verification of Licensure - If your pharmacy holds a current pharmacy license or ever held a pharmacy profession license, verification of licensure will be required to be submitted directly to this office by the licensing agency of any state of the United States in which you hold or ever held a license. In order to apply for a license or submit a service request, you must first have a DELPROS user account. Batch number. (5) A fee of rupees fifty shall be paid for a duplicate copy of the certificate of registration if the original is defaced, damaged or lost, and such copy of the certificate shall bear the words "Duplicate Copy". 13. (2) Where a person possesses or applies for a licence to manufacture by way of formulation and he also intends to conduct repacking of drugs, he may conduct such repacking under the same licence subject to the approval of, and under such conditions as, the Central Licensing Board may specify. (c) Recommended storage conditions and expiration date to be assigned to the specific formulation and package.. HTML PDF: 246-945-246: Wholesaler. (b) the content of active ingredient(s) per dosage form or regimen; Signature of the Analyst. 6.6.2 Reprocessing Address (iv) adequate precautions for safe-guarding the health of the workers, including measures to avoid industrial accidents or diseases. The importation into Panama of narcotic, controlled and restricted drugs is subject to import licensing to ensure that traders' procedures are in conformity with Panama's international obligations (Single Convention on Narcotic Drugs 1961 and Convention on Psychotropic Substances 1981). 42. (2) Power Mixer or granulation mixer with stainless steel cabinet (3-A) Application for renewal of registration of a drug shall be made in Form 5-B. For this purpose, it is desirable that each tablet machine is connected either to an exhaust system or isolated into cubicles. Sodium Iodide. FORM -5(A) Licensing Requirements. The text shall be fully legible. PH of the solution wherever applicable. (d) any directions for. (3) Taking into account the media employed, advertisements to the general public may amongst others, contain, he following information:- (3} Granular Ensure contact between gas and microbial cells ENCLOSURE OF THE APPLICATION FOR REGISTRATION OF A DRUG To LOG IN or CREATE a DELPROS (Delaware Professional Regulation Online Services) user account: Go to: https://delpros.delaware.gov/OH_HomePage. If the license you are reciprocating was obtained on or after June 22, 1976, and before May 12, 1986, minimum passing general average score of 70; or If the license you are reciprocating was obtained on or after May 12, 1986, minimum passing converted score of 75. c. Multistate Pharmacy Jurisprudence Exam (MPJE) - Pass with a minimum score of 75. General (5) Mixing tanks for processing medicated dressings. (w) "intermediate product" means partly processed material that must undergo further manufacturing steps before it becomes a bulk product; or PharmD) is required to sit for the North American Pharmacist Licensure Examination (NAPLEX). Maximum temperature. 4.9.1 Health examination (c) Identification. Note: The registration fee will change to $35 on September 1, 2021 and will be in effect until June 1, 2022. 6.10 Waste materials (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; 9.2.3 Validation of equipment if materials The application fee is $147. SCHEDULE G Pharmacy Services Health Department KP. Date of release of finished packings for distribution or sale, (ii) sufficiently clean, appropriately ventilated toilet facilities, including facilities for washing and room for changing clothes, shall be available for the use of manufacturing personnel where required; (a) Description. 5 wherever necessary. (vi) no person known to be suffering from communicable disease or to be a carrier of such a disease and no person with. 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 Methyl Salicylate. (2) Post-marketing scientific studies and surveillance shall not be misused as a disguised form of promotion. Value of raw materials used (Active & inactive) (in Rs.) (10) Rejection of an application for the registration of a drug shall not debar an applicant from submitting a fresh application under rule 26. Substances Parenteral preparation in general: SECTION--5 16, Records on the disposal of rejected batches and batches with-drawn from the market. 8. Name and quantity of drug(s) to be manufactured for the said purposes:. (ii) Reasons thereof. 4.6 Duties of Production Incharges 2.3 Products sterilized by filtration Advertisements shall also indicate, where applicable, appropriate limitations to the use of the drug. and Denmark. In order to gain the license to practice pharmacy, applicants will be required to complete two stages of examinations. 3.1 Quality Control Department SCHEDULE F 4.9.4 Reporting health problems Though licensing applications and processes differ from state to state, everyone will need the following: Proof of graduation from an accredited institution; [See rule 30 (11)] EQUIPMENT FOR PRODUCTION Composition of the drug, stating quantity of each active and non-active ingredient(s) per unit or as a percent age of total formulation : Frequency of use of filter General 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. (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. The premises and plan will be ready for inspectionon or are ready for inspection. Note//: This Schedule gives equipment and space required for certain categories of drugs only. The application can be extensive and is usually accompanied by fees, a surety bond, proof of insurance, and copies of policies, procedures, or prescription labels. (15) Labelling and packing benches, Validation (i) the name and address of manufacturer or distributor; [--] Alniminium Hydroxide Gel Dried. GENERAL CONDITIONS 1. Promotional material shall be factual and claims for cure, prevention or relieve of an ailment shall be made only if this can be substantiated. 7.4.5 Printing operation checks Insulin. Documentation 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. Processing (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. 6.1.1 Quarantine 49. Pharmacy Intern Application Instructions Completed Application:Applications may be submitted online at MyLicense.IN.govor completed by paperand mailed to our office. 12,500 Medical Representatives.- (1) Medical representatives shall have an appropriate educational background. (e) any error in the labelling of that drug; 6.9 Reference standards 17. 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. Main Pharmacological group to which the drug belongs: Must first have a DELPROS user account job as a pharmacist in the state of Maharashtra, you! 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