Observe Drug and Food Online Circulation Supervision Regulation

Observe Drug and Food Online Circulation Supervision Regulation

Medicines and Processed Foods that are circulated online must have a circulation permit, but ready-to-eat foods are excluded from such obligations.

The COVID-19 pandemic period requires people to implement social distancing. One of the effects of social distancing is that people buy their daily needs online, so they don’t have to leave their residence. This is also supported by the increasing number of applications that sell food and medicine online. So how is the control of drugs and food, which are sold online, carried out during COVID-19?

National Agency of Drug and Food Control (BPOM) has just issued a Regulation on the Supervision of Medicines and Foods that are Circulated Online. PerBPOM No. 8 of 2020 regulates the supervision of activities related to the distribution and/or delivery of drugs, traditional medicines, health supplements, cosmetics, and processed food using electronic transaction media in the context of trade.

• Online Drug Distribution
  In this regulation, drugs that are circulated online must have a circulation permit and must meet the good production and manufacturing requirements for drugs. Pharmaceutical industry, pharmaceutical wholesaler, pharmaceutical wholesaler branch and pharmacy can distribute drugs using electronic systems. But it is mandatory to ascertain that the drugs they circulate meet the safety, efficacy and quality requirements in accordance with statutory provisions.

  In addition, the pharmaceutical industry, pharmaceutical wholesaler, pharmaceutical wholesaler branch, and pharmacy is required to provide reports that at least contain:

  1. Name and address of the said pharmaceutical industry, pharmaceutical wholesaler, pharmaceutical wholesaler branch, and pharmacy;
  2. Date, month, and year the start of drug circulation online;
  3. Name of PSEF (Electronic Pharmacy System Provider) and website address/Uniform Resource Locator (URL) for pharmacies that collaborate with PSEF in organizing drug distribution online;
  4. List of drugs circulated online; and
  5. Transaction data of the drugs that are circulated online.

For the record, online drug distribution carried out by the pharmaceutical industry and pharmaceutical wholesalers can only be carried out using the Electronic Systems of the Pharmaceutical Industry and Pharmaceutical Wholesalers. Meanwhile, the Pharmaceutical Wholesaler Branch can only distribute drugs online using the Electronic System that belongs to the Pharmaceutical Wholesaler.

Furthermore, drug delivery that is carried out online by a pharmacy can use an electronic system which is owned by the pharmacy and/or provided by PSEF. Pharmacies and PSEF must ensure that the electronic systems used meet the following conditions:

• 1. Able to correctly inform at least regarding:
     1. Name of the pharmacy that provides services based on permit;
     2. Pharmacy Service Provider Permit;
     3. Owner of facilities;
     4. Name of the pharmacist in charge;
     5. License number for the practice of the pharmacist in charge;
     6. Address and telephone number of the Pharmacy Service Provider;
     7. Location of global positioning systems; and
     8. Trade/generic name, active substance, strength, contents of package and product circulation permit number.
  2. Ensure access and security of the use of the system by users in accordance with the given authority;
  3. Provides an electronic data backup system;
  4. Can be accessed by the Inspector at any time;
  5. Provides automatic and sequential checking and searching functions in regards of ordering drugs by patients to the pharmacy provider, based on the following considerations:
     1. completeness or availability of drugs;
     2. convenience/location closest to the patient; and/or
     3. drug prices.
  6. Provides the function of delivering electronic prescriptions and copies of electronic prescriptions;
  7. Provides electronic copy prescription function;
  8. Provides drug information services in accordance with the label;
  9. Provides a real time communication function between the patient and the pharmacist; and
  10. Displays information that patients are required to submit original prescriptions for hard drugs.

      Drugs that can be circulated online are drugs that are included in the group of free drugs, limited free drugs, and hard drugs. Hard drugs submitted to patients must be based on an electronically written prescription in accordance with statutory provisions; in addition, the drug must be in an amount appropriate to the therapeutic needs.

• Circulation of Traditional Medicines, Health Supplements, and Cosmetics Online
  Businesses that circulate traditional medicines, health supplements, and cosmetics that are circulated online must meet safety, efficacy/benefits, and quality requirements. Circulation can be carried out via:
  1. Owned Electronic Systems; and/or
  2. Electronic system provided by PSE.

Business operators and PSEs are required to ensure that the electronic system used meets the requirements:

1. 1. Can correctly inform at least regarding:
      1. Name and address or identity of the seller of Traditional Medicines, Health Supplements, and/or Cosmetics in a clear and traceable manner;
      2. Data and/or information stated on the marking of Traditional Medicines, Health Supplements and/or Cosmetics in accordance with statutory provisions.
   2. Obtain a mechanism for recording/documenting the distribution of Traditional Medicines, Health Supplements, and/or Cosmetics products that are circulated online.
   3. Data and/or information as referred to in paragraph (2) letter a number 2 may be in the form of written information and product images that display the entire marking section and/or other information.

Furthermore, the delivery of Traditional Medicines, Health Supplements, and/or Cosmetics can be carried out independently by Business operators or in collaboration with Third Parties in the form of legal entities. The requirements are as follow:

• 1. Ensuring that the condition of the packaging of Traditional Medicines, Health Supplements, and/or Cosmetics products during delivery to the recipient is intact and undamaged;
  2. Sending Traditional Medicines products, Health Supplements, and/or Cosmetics in closed containers;
  3. Ensuring that Traditional Medicines, Health Supplements, and/or Cosmetics products are delivered to their destination; and
  4. Documenting the handover of traditional medicine products, health supplements, and/or cosmetics including from third parties to buyers or consumers.
• Circulation of Processed Food Online

Processed food that is circulated must have a circulation permit and meet a good production method. However, there are exceptions to circulation permit obligations, which apply to:

1. 1. Pre-Prepared Processed Food; and
   2. Processed food which is further used as raw material by business operators and is not sold directly to end consumers.

Food Additives (BTP) are also included in the mandatory requirements to have a circulation permit and meet good production methods.

Businesses that circulate processed food online must ensure the safety and quality of processed food.

Business operators and PSEs carrying out online food processing circulation must ensure that the Electronic System used meets the requirements as follow:

• 1. Include information about the name and address of the Business Operator selling Processed Food.
  2. Include information and/or notification contained on the Processed Food label in accordance with statutory provisions.
• Prohibition
  1. Pharmacies and/or PSEFs are prohibited from distributing drugs online that are as follow:
     1. Hard drugs that are included in certain classes of drugs based on the statutory provisions;
     2. Drugs containing pharmaceutical precursors;
     3. Drugs for erectile dysfunction;
     4. Preparations for injections other than insulin for own use;
     5. Implant preparations that require the assistance of health professionals for their use; and
     6. Drugs that is included under the Narcotic and Psychotropic category.
  2. Business operators are prohibited from distributing Cosmetics that are as follow:
     1. Cosmetics skin preparations containing alpha hydroxy acid (AHA) with levels greater than 10% (ten percent);
     2. Cosmetic teeth whitening preparations containing and/or releasing hydrogen peroxide with levels greater than 6% (six percent);
  3. Alcoholic beverages are prohibited from being distributed online.
• Penalty

Administrative sanctions for business operators, PSE, and/or PSEF that violate the provisions, namely:

1. 1. Warning;
   2. Stern warning;
   3. Recommendations for closure or blocking of Electronic Systems belonging to Pharmacy, Electronic Systems belonging to the Pharmaceutical Industry, Electronic Systems belonging to Pharmaceutical Wholesalers, merchants in PSE’s Electronic Systems, Social Media accounts, Daily Deals, Classified Ads and other internet media used for electronic commercial activities (e-commerce);
   4. Recommendation for revocation of pharmaceutical service facility permit;
   5. Temporary prohibition of circulation; and/or
   6. Order to withdraw drug and food.

If your company or business needs assistance in obtaining circulation permit, please contact us via ask@bplawyers.co.id or 082112341235.